Vantive: A New Company Built on Our Legacy Since last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company. Vantivewill build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don t settle for the mediocre. Each of us are driven to help improve patients lives worldwide. Join us as we revolutionize kidney care and other vital organ support. Job Summary Job Title - Research Associate III (Testing Coordinator) Location - Whitefield, Bangalore Shift - General This position is responsible for The Testing Coordinator will utilize his/her scientific knowledge to own operational excellence and continuous improvement; This role involves streamline processes; coordinate business, management, and technical SMEs; identify risks; devise solutions, all to support the establishment of Operational excellence. Essential Duties and Responsibilities: Provide business and execution leadership for multiple analytical and stability-related projects and holding accountability for testing schedules, risks, and interacts with all functions and levels of management ensuring effective communications. Lead internal initiatives that enhance operational excellence. Interact with platform core team leaders and other key business stakeholders to be able to proactively anticipate business needs. Process inputs from Global Analytical, Stability Functional Leader and Analytical leads and Stability SMEs to determine schedules and forecast resource allocations to projects. Ensuring the availability of all prerequisites for scheduled laboratory analytical and stability testing. Master the planning of activities for testing and ensure on-time completion of all testing activities. Effectively coordinate testing with global teams and CROs as applicable to meet the KPIs on time. Interact with other testing groups (Particle, Sterility/BET, etc.) to determine schedules and alignment with business needs/function commitments. Ensure the maintenance of laboratory compliance as per regulatory requirements. Ensure import licenses are in place and manage laboratory samples inventory. Coordinate with procurement and technical teams for on-time procurement of chemicals and resolution of analytical instrument problems. Coordinate with external and internal sample shipment personnel s for receiving testing samples on time. Participate in handling of laboratory investigations that correspond to atypical or out-of-specification / out-of-trend test results and other nonconformance records and leverage critical thinking skills to drive the investigation to conclusions based on sound scientific principles and propose appropriate corrective and Preventive root causes. Author/Follow SOPs of relevant procedures. Qualifications: Proven experience in stability testing, analytical method validation and transfers, laboratory management, or a similar role. Strong leadership and project management skills. Excellent communication and interpersonal skills. In-depth knowledge of relevant QSRs, GxP, and other regulatory requirements. Handling of software like Trackwise. Proficiency in resource planning and inventory management. Critical thinking and problem-solving skills. Ability to work effectively in cross-functional and global teams. Proactive and able to anticipate business needs and challenges. Basic computer skills (MS Office Word, Excel, PowerPoint, etc.) Education: Master s in chemistry or Pharmaceuticals, with 6 to 10 years of experience. Education and/or Experience: Bachelor s degree with 8-14 years or Master s degree with 5 to 10 years of experience in relevant scientific discipline (Analytical chemistry/Pharmaceutical chemistry).

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. About Vantive Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Job Description You will be supporting the team responsible for developing solutions to challenging issues associated with the design, development, and sustenance engineering for our new and existing Disposables for the Acute Therapies product portfolio. You will be expected to support and contribute to the Projects/Initiatives involving Engineering change management, solutions for Product quality issues, root cause analysis, NCR handling, CAPAs, verification & validation, design transfer, Value improvement programs and Regulatory compliance activities. The successful candidate will possess solid “hands-on” technical abilities, an excitement and energy for product development, and a passion for their work and the impact it has on meeting the needs of patients. Essential Duties and Responsibilities: Supports the R&D development and sustenance activities to execute global cross functional projects relating to Acute Therapies Disposables. Should have good understanding of principles of mechanics, thermodynamics, hydraulics, heat transfer, and materials to support development and sustenance activities of mechanical and Fluid flow systems involving injection molded components and soft tubing. Will work with senior members/SME of the team to carry out root cause analyses in case of product failures with minimal supervision Supports the R&D function to execute Lab testing activities relating to Acute Therapies Disposables. Support R&D engineers in Test fixture creation, Test set up readiness and test method validation Follow instructions and Test protocols with limited guidance from R&D engineers during Test execution. Support in Developing and Executing Test Procedures/Functional Requirements testing/Performance testing. Develop and Perform Design Verification & IQ/OQ/PQ where applicable. Will be responsible for project management activities which includes managing change controls tasks–using Vantive’s in-house tools like Trackwise8 and Team Center Unified. Will work with senior members/SME of the team for writing of verification/validation test, test cases and documenting results in the form of technical reports Able to design Plastic components with inputs from senior team member/SME. Support for Instrument Management and Calibration Support consumable management/Logistics/ Tracking of parts. Support Project execution support for tests involving Reliability equipment’s and Thermal Chambers Follow safety guidelines and monitor the same for Lab operations. Trouble shoot unfavorable test outcomes and perform RCA. Works with external vendors for Transport validation, Stability, Sterilization tests, etc,, for Acute Disposables sets & accessories to define the test scope, author the test plans, test procedures, execute & consolidate the reports Collaborate with key stakeholders to resolve tests-related technical issues. Education and Experience Graduate or Postgraduate in Mechanical Engineering/ Polymer Technology/Plastic Technology/Bio Medical engineering or Equivalent. Minimum 2 years of product life cycle experience. Prior experience of technical and project leadership in Sustenance/New product development in Medical device or other highly regulated industry Prior experience in Design and Development of Single use medical device is a plus. Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Conduct testing and analyses of electromechanical medical devices through all stages of the development from prototype to design verification/validation stages. Essential Duties and Responsibilities : Execute and perform verification & validation activities as per defined plan and protocol. Responsible for independently verifying and validating with minimal supervision. Develop and manage processes and tools required to support the verification and validation activities. Providing technical support as applicable. Clear understanding and proven experience on basic requirements of unit, integration and system level verification and validation requirements. Responsible for maintaining and upgrading the tools and methodologies used for the verification and validation activities. Ensures good documentation practices are followed in the V&V process. Identify and report any quality or compliance issues during verification & validation activities. Diagnose, isolate and investigate the problem reports, as applicable. Works with external test houses such as EMI, EMC tests for electrical boards and full device) to define the test scope, author the test plans, test procedures, execute & consolidate the reports Participate in V&V process continuous improvement and test automation activities. Adheres to Baxter Quality Management system Qualifications : Bachelor's Degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field. Education and/or Experience: 3 to 6 years of experience in Verification and Validation of Software, Hardware and System. Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don t settle for the mediocre. Each of us is driven to help improve patients lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Draft, review and submit or support submission of Regulatory filings for Drugs and Medical devices (Re-registrations/ New Registrations/ Legal-Physical manufacturer transfer) for India/Sri Lanka/Bangladesh and Nepal Draft, review and submit or support submission of other Regulatory submissions for Drugs and Medical devices (Query responses, Corrections fillings, miscellaneous notifications regarding post registration regulatory lifecycle management) for India/Sri Lanka/Bangladesh and Nepal market in accordance with applicable regulations and relevant guidelines. Participates in the development and implementation of the regulatory strategy for drugs and medical devices Conducts regulatory monitoring of approved products by ensuring maintained files are current, ensuring regulatory compliance, evaluates the effects of an amendment or change and takes appropriate regulatory actions. Able to develop and implement appropriate regulatory strategies for the responsible countries to ensure business optimization. Monitor, track and provide project updates. Support, supervise and review team projects before submission to relevant authorities. To liaise with global regulatory team in obtaining materials for regulatory submission purposes, product related query from business and to address questions and issues which arise as part of registration. Participate and maintain working relationships and providing regulatory intelligence to relevant functional and business units team members. Support and assist supervisor in preparation of technical presentations/ meetings with the regulator and on various assigned tasks. Assist in preparation, review and maintenance of labels, SOP s, and other departmental documents. Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice .

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don t settle for the mediocre. Each of us is driven to help improve patients lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Tender Management Driving operational excellence in tender participation by following 1 st time right approach. Submission of tender 3 days in advance. Regular monthly connect with internal stakeholders to drive document fitness. AR Management- Ensure the timely payments from major Govt institutes so that the AR/Bad Debts are under control. Revenue Management- Keeping track of major tenders and sharing the timely forecast to BU teams to ensure the organization achieves the financial goals. Document Fitness Effective coordination with Regulatory affair. Drive 100 % document fitness Timely execution of LA agreements Process Orientation Adhere to all organization policies and procedures and set an example for all team members in context to work ethics and commitment Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice .

Essential Duties and Responsibilities: Responsible for defining, implementing, executing, and documenting embedded software for Baxter s peritoneal dialysis device portfolio. The activities will encompass all facets and phases of software development & test and life cycle management, meeting all regulatory and quality standards to realize complex, innovative, reliable systems that improve the quality of life for people around the world. Collaborate with other engineering and functional organizations to understand and define product use cases and convert these use cases into software requirements and design implementations. Own and lead all activities of software sub-system development and life-cycle management including sub-system development plans, SW requirements development, code development and optimization, unit and integration testing, SW risk and reliability analysis, root cause analysis. Transform software requirements into software architectures and verify that all software projects adhere to architecture standards. Lead concept selection efforts and design alternatives. Devise simulator solutions for the product portfolio. Drive research on emerging software architecture techniques and standards. Champion technical and industry trends related to software design and development Ensure all interface requirements are documented. Provide leadership to teams of engineers in multiple sites. Define the test automation strategy and implementation. Coordinate the software test activities with all other engineering disciplines, including external development partners. Qualifications Graduate or Post Graduate in Computer Science or related Engineering and 10 - 15 years of experience, including technical leadership. Prior experience in Renal device domain is a plus. A demonstrated track record in embedded software development, preferably medical devices or other highly regulated products such as military hardware. A proven track record of effectiveness in a fast paced environment. Experience in algorithms, code optimization, encryption, multiple language support C, C++, Assembly ARM processor development. Ability to work in a Linux development environment ARM / AVR processor development FPGA programming skills Intel embedded X86 development a plus Experience in embedded RTOS development Experience with USB, Ethernet, RS232 communications protocols Experience with sensor sampling Ability to develop boot loader code for microcontrollers Working level knowledge with standards such as IEC 62304, IEC 62366, IEC 60601, ISO 13485 and ISO14971 would be a plus.

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. About Vantive Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Job Description You will be supporting the team responsible for developing solutions to challenging issues associated with the design, development, and sustenance engineering for our new and existing Disposables for the Acute Therapies product portfolio. You will be expected to support and contribute to the Projects/Initiatives involving Engineering change management, solutions for Product quality issues, root cause analysis, NCR handling, CAPAs, verification & validation, design transfer, Value improvement programs and Regulatory compliance activities. The successful candidate will possess solid “hands-on” technical abilities, an excitement and energy for product development, and a passion for their work and the impact it has on meeting the needs of patients. Essential Duties And Responsibilities Supports the R&D development and sustenance activities to execute global cross functional projects relating to Acute Therapies Disposables. Should have good understanding of principles of mechanics, thermodynamics, hydraulics, heat transfer, and materials to support development and sustenance activities of mechanical and Fluid flow systems involving injection molded components and soft tubing. Will work with senior members/SME of the team to carry out root cause analyses in case of product failures with minimal supervision Supports the R&D function to execute Lab testing activities relating to Acute Therapies Disposables. Support R&D engineers in Test fixture creation, Test set up readiness and test method validation Follow instructions and Test protocols with limited guidance from R&D engineers during Test execution. Support in Developing and Executing Test Procedures/Functional Requirements testing/Performance testing. Develop and Perform Design Verification & IQ/OQ/PQ where applicable. Will be responsible for project management activities which includes managing change controls tasks–using Vantive’s in-house tools like Trackwise8 and Team Center Unified. Will work with senior members/SME of the team for writing of verification/validation test, test cases and documenting results in the form of technical reports Able to design Plastic components with inputs from senior team member/SME. Support for Instrument Management and Calibration Support consumable management/Logistics/ Tracking of parts. Support Project execution support for tests involving Reliability equipment’s and Thermal Chambers Follow safety guidelines and monitor the same for Lab operations. Trouble shoot unfavorable test outcomes and perform RCA. Works with external vendors for Transport validation, Stability, Sterilization tests, etc,, for Acute Disposables sets & accessories to define the test scope, author the test plans, test procedures, execute & consolidate the reports Collaborate with key stakeholders to resolve tests-related technical issues. Education And Experience Graduate or Postgraduate in Mechanical Engineering/ Polymer Technology/Plastic Technology/Bio Medical engineering or Equivalent. Minimum 2 years of product life cycle experience. Prior experience of technical and project leadership in Sustenance/New product development in Medical device or other highly regulated industry Prior experience in Design and Development of Single use medical device is a plus. Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice. 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Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Essential Duties And Responsibilities Takes complete Ownership of testing a product or release and ensures high quality deliverables Formulate end to end V&V strategy for a product/subsystem Plan, design and execute agile testing and verification activities of the program/project in consultation and alignment with team Participates in review of Requirements, Test Plans and test cases Lead a team of test engineers Creates and maintains traceability for the subsystem/product Demonstrate the ability work with team members. Applies principles of SDLC and methodologies like Lean/Agile/XP, CI, Software and Product Security, Scalability, Documentation Practices, refactoring and testing techniques. Participates in continuous improvement activities by identifying and appropriately escalating process and product quality gaps. Qualifications / Experience And/or Background Experience in manual/automation software testing. Well versed with software testing techniques Strong experience in Python and/or any other programming language Experience in test automation of embedded systems Experience in technically leading a team of test engineers. Expertise in Test design, test data creation and maintenance Experience in Medical/Healthcare domain is a plus Demonstrated success in delivering results on technical challenges Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice. Show more Show less

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. The Sr. Specialist, Learning Technology is responsible for analyzing and documenting recommendations around eLMS patches / releases. This includes the evaluation of potential impacts from the quarterly releases. They will be responsible for getting appropriate sign-offs. The Asst Manager, Learning Technology is also responsible for performing validation activities along with the validation experts from Business and IT. Responsibilities: This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. Own key tasks, demonstrate solid business knowledge, require moderate direction, give minimal guidance to others, handle moderately complex problems, possess solid knowledge of Learning Technologies. Gather, understand and document business objectives, specifications and requirements on small/medium size projects. Configure and test the updates as needed before making a recommendation on whether or not to “turn on” functionality. Define, design, and document business flows and processes on small & medium size projects. Document each update’s impact on current processes and any potential risks. Share finding's with Learning COE and IT Groups for needed sign off before implementing updates. Define and articulate business rules required for data accuracy and consistency. Identify and resolve data quality issues. Act as the primary contact for the data management process between IT developers and the business. Provide end-user support on applications supported within the organization. Identify, analyze, propose and document appropriate solutions for problems and issues that may impact the project. Identify and understand issues that may impact day-to-day operations and/or project costs. Use technical tools for (queries, process maps, etc) for problem resolution. Understand and follow appropriate quality validation processes and application processes. Communicate status, solutions and concerns. Disseminate information in a timely manner within the team and across functions or teams. Establish and maintain relationships within the business or function. Provide cross-functional and business knowledge to develop business system and process alternatives. Train others as appropriate on specific area of business or systems expertise. Assist in development of training materials Through knowledge of setting up CSOD LMS from scratch is must. Validation: Working knowledge of validation related tasks and activities. System Knowledge: Thorough understanding of eLMS and dependent systems to be able to understand dependencies of releases. Detail Oriented: Ability to document details and interdependencies regarding a release update. Strategic Thinking: Ability to understand implications of releases and provide recommendations to COE about specific release acceptances. Bachelor’s degree preferred or relevant work experience in Learning systems or business. 5+ years experience in applying information systems solutions to business problems. Experience in system testing, validation, problem resolution, and training. Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice. Show more Show less

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities, Vantive: A New Company Built on Our Legacy Since last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company Vantive will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us, At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us are driven to help improve patientslives worldwide Join us as we revolutionize kidney care and other vital organ support, Summary The Lead System Integrator (LSI) team is a part of the R&D organization that supports the Kidney Care business segment Within the team, we provide R&D focused project management support for all product phases, innovation initiatives, new product development and improvement programs for existing therapy systems, Vantive is a global company with R&D sites at multiple locations in the world; competences and capabilities are spread over the different R&D sites, and you will commonly collaborate with colleagues across several of these R&D sites and with other functional representatives Work assignments within the team are highly variable and we can promise you a work environment with exciting project management challenges and variability in your day-to-day activities, The Kidney Care R&D Drug Products and Sciences (DPS) organization is responsible for Kidney Care drug products (dialysis solutions, concentrates, etc) and related sciences (Sterility Assurance, Analytical Chemistry, materials compliance, Extractables & Leachables, Toxicology) As a member of the Drug Products and Sciences organization, the Lead System Integrator co-ordinates/leads DPS R&D activities within a Project or Program with her/his Project Management and Technical Leadership skills This role may be responsible for supporting multiple projects, Essential Duties and Responsibilities This section contains a list of five to eight primary responsibilities of the work The incumbent will perform other duties as assigned, Lead research and development (R&D) project management work for drug products, medical devices, and other regulated healthcare products Owner of R&D program schedule creation, tracking, and execution Integrate inputs from all DPS competencies/subject matter experts into a harmonized project proposal, project schedule, technical risk assessment, and other project plans, Participates as a member of cross functional teams and/or integrates cross functional inputs into project deliverables Accountable for project execution and proactive risk management Effectively tracks project status, risks, budget, and external spend, Demonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards Prepares project reports, analyses and delivers presentations to R&D leadership on a regular basis Leads scheduled meetings in R&D, develops and manages agenda, creates minutes, and follows up action items throughout the project Establish project communication channels and archives e-g , Teams group, Status meetings, Escalation matrix, etc Facilitate/organize DPS R&D project design reviews and change control meetings Facilitate purchase orders (POs) and approve corresponding invoices for the R&D tasks executed by external vendors (e-g , external labs, translation agencies, etc ) Across multiple parallel projects, identify and evaluate interactions/dependencies and potential synergy opportunities Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily List knowledge, skills, and/or abilities required, Experience in project management principles and methodologies Strong interpersonal and communication skills in written and verbal form Demonstrated ability to draw conclusions and make recommendations based on technical inputs from multiple and varied functions (Marketing, Quality, Regulatory, etc ), Ability to provide technical leadership and coordination for medical product projects with substantial complexity and scope, Ability to decompose complex problems into actionable plans and track them to closure Understanding of design requirements for development, validation, and verification of medical products Education and/or Experience Include the education and/or experience that is necessary to perform the job satisfactorily, Bachelors degree in Engineering, Science or related field 10+ years of relevant R&D, Project management (or similar) experience preferred Experience in pharmaceuticals or medical product industry preferred Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice,

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities, The Engineering Project Leader works with people around the world to support our global installed product base, In this role you will lead several Product Design Change initiatives for Baxters global Acute Therapies products, You will be expected to manage Design Change Projects from proposed initiative inception to final production implementation and market rollout, Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice,

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities, Summary The successful candidate for this role will bring familiarity and experience in characterization and failure analysis of polymeric materials pertinent to use in drug and device industry The role requires the candidate to perform polymer material testing at in-house labs and/or coordinate the testing with external testing labs under minimal supervision The individual will write required reports following pertinent internal and external guidelines that enable the eventual use of polymer materials tested by them in drugs or devices manufactured by Vantive, Essential Duties And Responsibilities, Perform characterization and failure analysis of polymeric materials used in multiple applications such as disposables (e-g filters, dialyzers, polymeric connectors etc ), packaging, and container closure materials and container systems, Employ appropriate techniques/methods to successfully and independently execute assignments within negotiated deadlines, Apply technical theories and principles to projects within area of expertise and select appropriate techniques and procedures to solve problems, Document results in laboratory notebooks/ELN according to established GDP procedures, Maintain laboratory reagents, materials and equipment as directed in good order, Create and update equipment SOPs and analytical procedures, participate in ordering of raw materials, analytical materials or equipment, Maintain knowledge of and apply relevant quality and safety requirements including equipment ownership and qualification, Have a working knowledge and understanding of GDP, GLP, GMP and related regulations and guidelines, Qualifications, Demonstrated hands-on experience in polymer characterization (FTIR, DSC, TGA, MFI, etc ), polymer microscopy and associated sample preparation techniques (microtomy/cryomicrotomy), as well as experience in failure analysis of polymers required, The successful candidate will demonstrate high level of passion and interest in polymer science and applications of that knowledge to be an effective problem solver in an industrial setting, Excellent written and verbal communication skills in English, Ability to effectively contribute as an integral member of a project team, Ability to objectively assess, organize, and clearly communicate information, Ability to interpret available information and make recommendations to resolve technical challenges, Ability to appropriately prioritize work assigned to meet project deliverables in a timely manner, Demonstrate inclusive attitude, collaborate with team members and cross-functional teams for project deliverables, Contribute to efforts beyond own scope of responsibilities to ensure project milestones are met, Provide and accept critical feedback from others in a constructive manner, Adapt to changes and exhibit an agile mindset, Embrace diversity and inclusion, value differences, Education And/or Experience, Mastersdegree in a relevant field (e-g , Material Science/Chemistry, Polymer Science/Chemistry) with 2 yearsof relevant professional experience, PhD candidates with dissertation work relevant to polymer characterization, polymer microscopy and polymer failure analysis are encouraged to apply, Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice,

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities, Vantive: A New Company Built on Our Legacy Since last year, we have been on a journey to separate our Kidney Care segment into a standalone company Vantive will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us, At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us are driven to help improve patientslives worldwide Join us as we revolutionize kidney care and other vital organ support, Job Summary Job Title Engineer IILab, Sterility Assurance & Microbial Sciences Location Whitefield, Bangalore Shift General This position will report to Sterility Assurance & Microbial Sciences Lab Manager and is primarily responsible for laboratory contract support This role will be responsible for the overall operation, maintenance and execution of various sterilization cycles in steam sterilizer The candidate should learn the technical aspects of sterilizer and should be able to troubleshoot routine challenges related to sterilizer by coordinating with vendors The candidate should have a strong understanding of the scientific aspects related to Microbiology and Sterility Assurance, Job Responsibilities Candidate working with a Device / Drug Company (Device preferred but would consider Pharma/ Biopharma)Microbiology & Quality Assurance/Control Should have a good knowledge of Regulations and GMP working environment Exposure to multiple products life cycle desirable, Contribute to technical feasibility analysis of complex research and design concepts including a lot of microbiology inputs for Sterility Assurance and related controls for the products, Good understanding of the Science & microbiology principles, guidance, regulations around sterilization validation & related to Sterility Assurance, Design, development & Technical Understanding of Microbial Method Validation & Sterilization Engineering principles for devices/ Solutions, Support Lab Manager by assuring contract laboratories documentation and internal lab documentation are audit ready and team can effectively respond to auditor inquiries, Work with Quality team to ensure adequate documentation, input into computer systems, and being the point person for addressing quality issues, Operation of steam sterilizer as per set procedure for various Sterility Assurance studies (Class-C & B studies), Prioritization of sterilizer cycles as per project need and urgency ensuring timely completion of project deliverables, To document all the sterilization study records manually or by using ELN templates, To learn and develop expertise in execution of different CCI methods (Air Under Water & Gurley), Responsible for calibration and maintenance of all laboratory equipment, Responsible for maintaining optimum inventory of lab consumables, Responsible for maintaining anytime audit readiness of Sterilization lab, Design and draft various study protocols as per project need, Equipment procurement and assure necessary validations and documentation, Support Lab Manager to maintain lab operations, Provide regular/timely updates to Sterility Assurance Management, Assure all work complies with Vantives QMS and cGDP/cGMP/cGLP practices, Perform standard Sterility Assurance assignments for application, validity and conformance to specifications, Utilize analytical process tools to solve complex process problems (e-g , FMEA, Risk Analysis, Process Modeling, Design of Experiments) Lead small project teams as needed to accomplish project objectives, Study and recommend techniques to improve existing products/processes and process controls, Provide sterilization support for Renal R&D projects and technical trouble shooting & to evaluate results relative to product requirements, definitions and/or program goals Analysis and evaluation of sterilization studies data and assist in the preparation of documentation using Good Documentation Practices (GDP), Employ appropriate techniques and methods to successfully conduct specific assignments within negotiated deadlines after receiving general instruction, Demonstrate working knowledge of basic technical theories and principles within area of expertise for routine tasks, Devise new approaches to complex problems through adaptations and modifications by use of standard technical principles, Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities, Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise, Ability to convince management on courses of action with minimal assistance using both written and verbal methods, Knowledge around microbiological aspects of biological indicators, Adventitious Agents and related microbiological concepts, Qualifications Masters degree in a scientific discipline (Microbiology/Technology/ Science/ Pharmacy) with minimum 6 years or BS with minimum 8 yearsexperience in sterilization validation or equivalent, Prefer experience with Sterilization, Global sterilization regulations & TQM methods (e-g "six sigma") Display a solid technical understanding of Microbiological principles and qualification practices & application of these principles on individual/small projects, Technical writing skills, remote support for projects, strong interpersonal skills and a quick adaptive mindset for the new technologies, Strong Microbiology background and experience, Demonstrated ability to utilize resources available to ensure compliant and required documentation for contract testing laboratories and the internal R&D microbiology department, Experience managing multiple simultaneous projects and work activities, In-depth knowledge of cGDP/cGMP/cGLP practices and compliant documentation, Effectively operates in, and capable of facilitating, cross-functional teams, Knowledge of Terminal sterilization and/or pharmaceutical industry, Skills Excellent English verbal and written communication skills, skilled to coordinate with global stake holders and support across the different time zones, Proficient with Sterilization principles and related testing for Biological indicators etc Hands on experience cycle design and development and performing the sterilization studies for devices with use of PCD /biological indicators, Highly adept at grasping and solving complex problems using root-cause analysis techniques, Ability to objectively identify technical solutions and make sound decisions Project management experience for Quality & value improvement projects Self-driven, resourceful, and able to work on multiple projects and priorities, Strong organization, attention to detail, and documentation skills, Strong acquaintance with technology, QMS tools and collaboration tools over the web: e-g Trackwise, Document tools, WebEx, Teams, Microsoft Office products, etc Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice, Show more Show less

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities, Sr Spec, IT RA Global Apps (Grade 17) Location: India (Remote/Hybrid Options Not Available) Company: Vantive Corporation About Vantive Vantive Corporation is a global leader in vital organ therapy healthcare, delivering innovative products, digitally enhanced solutions, and advanced services to support dialysis and ICU-based critical care Spun off from Baxter Kidney Care in February 2025, Vantive is committed to transforming kidney care and beyond, impacting over 1 million patient interactions daily in 100+ countries, We are seeking a Senior Specialist, IT QA RA Global Apps to serve as a System Owner and Functional Lead, responsible for ensuring Quality and Regulatory global applications meet business requirements and remain in a validated state throughout their lifecycle, This role requires hands-on experience with regulatory solutions such as Veeva RIM Vault or other Regulatory applications, Position Overview As the Sr Specialist, IT RA Global Apps, you will: Own and manage Regulatory applications, ensuring they are designed, operated, and maintained per business requirements, Serve as the functional business analyst, gathering and analyzing business needs, defining requirements, and architecting solutions, Lead system validation, testing execution, and change management in a regulated environment, Oversee system maintenance, upgrades, defect tracking, and issue resolution in collaboration with IT and business teams, Act as the primary liaison between IT, business process owners, and external vendors, Key Responsibilities System Ownership & Governance Serve as the primary system owner for Quality & Regulatory IT applications, ensuring compliance with GxP, 21 CFR Part 11, and Computer System Validation (CSV) requirements, Implement solutions that align with business needs and regulatory requirements, Maintain system documentation, including functional requirements, design specifications, validation plans, and change control records, Ensure systems remain in a validated state throughout their lifecycle, Functional Business Analysis & Solution Design Gather, analyze, and document business requirements, workflows, and process improvements, Translate business needs into functional and technical specifications, Collaborate with IT teams to develop and deploy configurable solutions in Veeva, TrackWise, LabVantage LIMS, and other Quality/Regulatory applications, Ensure solutions are scalable, compliant, and aligned with Vantives digital transformation strategy, Validation, Testing & Compliance Lead Computer System Validation (CSV) efforts, ensuring applications meet FDA, ISO 13485, and global regulatory standards, Develop and execute test scripts, UAT scenarios, and validation plans for new implementations and system changes, Manage risk assessments, audits, and regulatory inspections related to system validation and compliance, System Maintenance, Enhancements & Issue Resolution Oversee system upgrades, patches, and maintenance, recommending enhancements as needed, Manage issue triage, root cause analysis, and resolution for system defects, Work closely with business process owners to ensure applications align with operational needs, Coordinate with vendors and internal teams for system support and enhancements, Stakeholder Collaboration & Project Support Act as a key liaison between IT, Quality, Regulatory, and business stakeholders, Support global Quality and Regulatory IT projects, including new system implementations and digital transformation initiatives, Provide end-user training and support, ensuring smooth adoption of system enhancements, Assist with project management tasks, ensuring timely delivery of IT solutions, Technical Skills & Experience The Ideal Candidate Should Have a Strong Technical Foundation With Hands-on Experience In Enterprise Application Support, Configuration, And Deployment Key Technical Competencies Include Programming & Scripting: Basic understanding of Java, Dot net, and SQL, with the ability to analyze and troubleshoot application logic, scripts, and database queries, Cloud & Infrastructure: Knowledge of AWS or Azure, including experience with deploying, configuring, and maintaining applications in a cloud environment, Validation & Compliance: Experience working in a regulated life science environment with understanding of CSV (Computer System Validation) and GxP requirements, including writing and executing IQ/OQ/PQ scripts Cloud Computing and Data Management: Familiarity with SaaS environments (e-g , Veeva Vault Platform, Salesforce-based systems), including workflows, lifecycles, and user permissions, Regulatory Domain: Hands-on experience with platforms like Veeva Vault QMS, TrackWise Digital Understanding of regulatory process and submissions, including submission registration and publishing, promotional materials, etc regulatory authorities, global registration of products, The candidate should be able to collaborate with developers, business analysts, and cloud teams, ensuring seamless deployment, maintenance, and optimization of critical Quality and Regulatory applications, Soft Skills Analytical Thinking: Ability to analyze complex business requirements, map them to system capabilities, and identify gaps or risks Problem-solving skills to troubleshoot system issues while maintaining regulatory compliance, Communication and Collaboration: Strong verbal and written communication to liaise between IT, quality assurance (QA), regulatory affairs, and business stakeholders Ability to translate technical concepts into actionable insights for non-technical teams (e-g , explaining validation requirements to QA), Project Management: Basic project management skills to coordinate system upgrades (e-g , Veevas 3 annual releases), implementations, or process improvements Familiarity with methodologies like Agile or Waterfall, often used in IT projects, Attention to Detail: Precision in documenting system changes, validation protocols, and SOPs to withstand regulatory audits, Qualifications & Experience Must-Have Qualifications 3+ years of experience in IT business analysis, system ownership, or validation in Life Sciences/Pharmaceutical/Medical Device industry, Hands-on experience with Veeva, TrackWise, or other Regulatory/Quality applications, Strong knowledge of GxP, 21 CFR Part 11, Computer System Validation (CSV), and regulatory compliance, Ability to develop and execute test scripts, validation plans, and system documentation, Technical knowledge of SQL, system integrations, and application configuration, Bachelors degree in Computer Science, Information Systems, or a related field, Preferred Qualifications Experience with Veeva,Salesforce, AWS, Azure, or cloud-based environments, Basic project management experience (Agile, Waterfall, or hybrid methodologies), Strong problem-solving and analytical skills to address complex system issues, Excellent communication and stakeholder management skills, Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice, Show more Show less

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities, Job Summary Vantive is seeking a Technical & Functional professional with expertise in Laboratory Management Systems and other R&D application implementations to support digital transformation initiatives The ideal candidate will be the single point of contact (SPOC) of designated information technology systems, including but not limited to hardware, software, databases, & applications, This role requires a strong blend of technical expertise, hands-on implementation experience, and business process understanding to configure, integrate, and optimize these systems within a regulated environment, Key Responsibilities System Implementation: Lead end-to-end implementation of cloning OpenLab modules and other apps in R&D by collaborating with SI partners and vendors Develop and support Integrations/APIs, middleware solutions, and automation workflows, Perform system configuration, customization, and validations, Develop and implement standard operating procedures (SOPs), templates, and user access controls for compliance and efficiency, Conduct user training sessions, workshops, and documentation development to drive system adoption, System & Incident Management Monitor system performance metrics, identify areas of improvement, & implement optimization strategies to enhance efficiency and reliability, Identify and mitigate risks associated with system operations, data integrity, and/or cyber security threats, Alert and escalate technical issues, concerns to functional leads, architects, and/or program leads, Communicate with incident commanders and service desk in accordance with SLAs, Implement disaster recovery plans, backups, and system monitoring, Continuous Improvement Collaborate with BRM/MRM, EA, business owners, other IT functions, and/or with 3rd party system owners on system enhancements and capabilities to translate business requirements into technical designs that are globally scalable aligning with organization road maps, goals, and initiatives, Implement system upgrades and enhancements to improve systemsperformance, functionality, and/or security, Ensure the system is secure and up to date (patching, version, certificates etc ,) and the system is compliant with authentication policies, Compliance & Validation Support Ensure applications deployments meet GxP and FDA 21 CFR Part 11 standards, Assist in computer system validation (CSV) activities, including IQ/OQ/PQ documentation and audit readiness, Develop and maintain system risk assessments, validation scripts, and traceability matrices, Required Qualifications & Experience: Bachelors degree in computer science, Computer Engineering, or other related fields, 8 + years of experience in Information Systems, experience in multiple areas of IT, 3 5 years of experience in Open Lab or other laboratory management systems implementation & support, Experience with programming languages (e-g , C#, Dot net, Java, Python), web technologies (e-g , ASPDot net Core, Angular, REST APIs), and database technologies, Familiarity with software development tools and methodologies, including version controls systems, and testing frameworks, Experience with administration and maintenance of CI/CD and DevOps tools, including managing user accounts, performing system upgrades, handling license and certificate renewals, and ensuring high availability and security compliance across environments, Understanding of regulatory and compliance processes in industries such as life sciences, pharmaceuticals, or manufacturing, Additional Skills Basic project management experience (Agile, Waterfall, or hybrid methodologies), Strong problem-solving and analytical skills to address complex system issues, Excellent communication and stakeholder management skills, Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice,

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities, Vantive: A New Company Built on Our Legacy Vantivewill build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us, At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us are driven to help improve patientslives worldwide Join us as we revolutionize kidney care and other vital organ support, Job Title Principal Eng, Reliability Location Whitefield, Bangalore Essential Duties And Responsibilities Plan, schedule, and lead project assignments using appropriate engineering techniques, processes, and methods with minimal guidance, Identify and define Reliability related requirements from applicable product requirements, use profiles, and risk mitigations, Provide guidance to design teams in Reliability process execution using relevant methodologies, tools, and techniques, Collaborate with cross-functional resources (e-g systems, hardware, Service, Mfg ,Quality, etc ) involved in Reliability activities, Establish Reliability predictions, Reliability testing, and post-market metrics, Create and communicate plans, tasks, deliverables and status Manages time and resources to meet committed schedule milestones, Develop and maintain an effective and collaborative working relationship with internal and external development partners, Lead the troubleshooting and problem-solving efforts related to Reliability aspects of devices and associated systems, Support sustaining teams in Post Market events and Investigations, Participate in risk assessment activities, for example, DFMEA, to ensure reliability goals are appropriate for risk mitigations Qualifications Working experience on Electromechanical devices Design for Reliability life cycle Good understanding on standards like MIL-HDBK-217/ Telcordia and NPRD 95, Reliability modeling & allocation to set the reliability target for subsystems and components, Experience developing test strategies, protocols, reports and test method validation documentation, Working experience in designing / executing Accelerated Life Testing Working experience on statistical tools and processes (Field data analysis techniques like Weibull analysis) Planning and performing reliability growth and Reliability Demonstration Testing and expertise and fluency in Excel, Minitab, Windchill / Relex, Reliasoft, etc preferred, Certified Reliability Professional/Engineer (or equivalent) preferred, Strong interpersonal and communication skills in written and verbal form Education And Experience Bachelors degree in mechanical, electrical or bio-medical discipline, Post graduate degree in Reliability preferred, 10+ years of R&D experience; experience in medical device industry preferred Experience/expertise in the following areas: Design for Reliability planning and management, establishing Reliability Requirements & Goals, Reliability Prediction using different methods (e-g Parts count & Parts stress methods), Strong Working knowledge of Reliability Analysis (statistical techniques), process and methods Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice,

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities, Organization Vantive: A New Company Built on Our Legacy Vantive will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us, At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us are driven to help improve patientslives worldwide Join us as we revolutionize kidney care and other vital organ support, Summary The ideal candidate will leverage his/her exposure to embedded software and its interplay with electronics/hardware to support optimal system/product level realization for new products as well as sustenance of the existing products to deliver dialysis therapy You join our Systems engineering function which is a part of the larger R&D organization and collaborate across functions (Software, Hardware, V&V, Digital) and sites globally (QA, RA, Clinical, Service, Mfg), The successful candidate will possess strong technical abilities, an excitement and energy for product development, and a passion for their work and the impact it has on extending lives and expanding possibilities, Essential Duties And Responsibilities As a member of cross-functional team, integrates cross functional inputs to delivery of a project of minor to moderate complexity, Product Requirements creation, analysis and management, System integration and testing, Leverages knowledge of technology, process, and/or therapy domains to drive solutions and product design realization, Contributes through demonstrated hands-on participation with teams Accountable for direct production of project deliverables, Contributes to design concepts and research methodologies that meet current and future customer & business needs for a product or process domain area, Participates as a member of Design Review Teams, Ensures inclusion of inputs into product and technical design reviews from cross functional stakeholders, Proposes and drives solutions to technical problems, Engaged within the team May act as the leader for a subsystem for products of minor to moderate complexity or as a subject matter expert on technical problems, Understands and contributes to resolution of competing constraints within assigned function (e-g systems, electrical, software, or mechanical engineering) required to deliver products to market, Able to apply technical risk mitigation tools and execute mitigation strategies to ensure optimal results, Able to contribute to the program/project or the organizations technical strategy, Desirable Awareness of medical devices ISO and IEC design control procedures, regulations and standards, Qualifications Bachelors or higher engineering degree in Electrical/Electronics, Bio-medical, or related discipline, Proven experience as a systems engineer or a similar role, Proficiency in relevant software & systems tools & techniques, Strong analytical and problem-solving skills, A demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated products, Excellent communication and collaboration abilities, Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice,

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities, The Shared Services Team is the first point of contact for HR, Employees and Managers, with respect to HR service delivery, process workflow, and transactional support This role must have a service mindset focused on the employee experience with deep skills in listening and people interaction This role will be a key member supporting the HCM global system implementation Focus will be on APAC Region Essential Functions Support HR data integrity framework at a global level through execution of defined data management processes, Partner with cross-functional teams, HR Business Partners, and Global HR Team to provide support for HR processes while fostering teamwork and collaboration, Support system administration for assigned regional area, including workflows, approval paths, data governance, implementation of new features, and functionality enhancements, Conduct testing, documentation and technical training on HCM system functionality and execute assigned change management and communication initiatives (for assigned region), Support continuous improvement by adopting best practice and latest technology tools such as case management, chat bots, AI driven knowledge portal, help modules, journeys, etc Listen to and solicit feedback from customers and key stakeholders to help develop recommendations on processes that help enhance the end-user experience, Participate in councils, quality improvement teams, and other such committees as required, Provide support to key HR initiatives that help drive customer satisfaction, interaction quality, problem resolution, employee engagement, etc Qualifications Bachelors degree or local equivalent is required, Minimum of 10 years in HR, Basic knowledge of areas across human resources including talent acquisition, benefits, compensation, organizational design/development, M&A, employee communications, training and development, employee relations policies, etc Knowledge and understanding of intricacies of HR operations to maintain the credibility of HR Shared Services, Strong analytical skills with the ability to develop, test, and document HCM technology Change management is essential, Ability to prioritize, problem solve, and apply critical thinking skills, Excellent communication and listening skills, Ability to effectively address customer concerns while also maintaining adherence to standards, Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice,

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities, Technical Lead LabVantage LIMS Location: India (Remote/Hybrid) Company Overview Vantive is a leading MedTech company specializing in vital organ therapy innovations Our Quality and Regulatory IT team supports 18 manufacturing plants and corporate QMS operations globally, ensuring compliance with regulatory authorities such as the FDA, We are looking for a Technical Lead LabVantage LIMS to provide expert-level support for our on-premise EC2-hosted LabVantage LIMS system The candidate will play a key role in the lift-and-shift migration from Baxter to Vantive, system configuration, troubleshooting, and ongoing enhancements, Key Responsibilities System Administration & Support: Manage and maintain the LabVantage LIMS environment hosted on on-prem EC2 infrastructure, Troubleshoot application, database, and infrastructure-related issues, Monitor system performance and ensure uptime, Configuration & Customization: Configure workflows, rules, and business logic within LabVantage, Develop and maintain LIMS Master Data, sample management, and reporting configurations, Implement barcode scanning, instrument integration, and audit trail configurations, Integration & Automation: Support integration with external systems, such as ERP, MES, and regulatory submission tools, Work with SQL, Java, and LabVantages proprietary scripting tools for automation and customizations, Assist in the transition to AWS cloud-based solutions in the future roadmap, Validation & Compliance: Ensure 21 CFR Part 11, GxP, and FDA compliance, Prepare validation documentation, test scripts, and change control processes, Support periodic audits and system reviews, Project Management & Stakeholder Engagement: Work closely with global IT teams, business users, and vendors to gather requirements and deliver solutions, Collaborate with quality, regulatory, and lab operations teams to enhance system usability, Drive technical roadmap and enhancements for LabVantage at Vantive, Technical Expertise Required Skills & Qualifications: LabVantage LIMS (Version 8 x or higher) 5+ years of hands-on experience On-Prem EC2 Hosting Familiarity with managing applications on AWS EC2 Java, JBoss, and Web Services Experience in LIMS scripting, API development, and integrations SQL & Oracle DB Writing and optimizing queries, database administration experience Workflow Configuration & Master Data Management Setting up lab workflows, security roles, and user access GxP, 21 CFR Part 11 Compliance Experience in validated environments Lab Equipment & Barcode Integration Experience integrating LIMS with lab instruments Soft Skills & Leadership Strong problem-solving & troubleshooting skills Ability to lead technical discussions & mentor junior team members Excellent communication & stakeholder engagement skills Experience with ITIL frameworks, change management, and incident handling Preferred Skills (Nice To Have) Experience with AWS cloud migration strategies Exposure to Veeva QMS, TrackWise, or other Quality & Regulatory IT systems Prior experience in Medical Device or Pharma industries Qualifications & Experience Must-Have Qualifications 5+ years of experience working with LabVantage LIMS in a technical support/configuration role, Strong knowledge of LIMS system administration, workflows, and master data setup, Proficiency in JavaScript, Groovy scripting, or Python for system customization, Hands-on experience with API integrations (REST/SOAP) and enterprise system connectivity, Strong knowledge of AWS including cloud security, deployment, and infrastructure management, Windows/Linux servers, and infrastructure best practices, Ability to troubleshoot complex technical issues and implement effective solutions, Excellent communication and collaboration skills, with experience working in cross-functional teams, Experience in pharmaceutical, biotech, or medical device industries preferred, Bachelors or Masters degree in Computer Science, Information Systems, or a related field, Preferred Qualifications Familiarity with GxP, FDA regulations, CSV (Computer System Validation), and change control processes, Experience with SQL, Dot net, Java, or scripting languages for system troubleshooting and automation, Familiarity with ITSM tools (e-g , ServiceNow) and Agile methodologies, Certifications in AWS is a plus, Basic project management experience (Agile, Waterfall, or hybrid methodologies), Strong problem-solving and analytical skills to address complex system issues, Excellent communication and stakeholder management skills, Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice,

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities, Performs the activities associated with the Systems engineering of one or more products in various stages of the product lifecycle from new product development to post market surveillance, Gathers inputs for Requirements from various sources such as Standards, User needs, Regulatory, Quality, Human factors, Manufacturing, Service and so on Performs impacts assessment on the requirements on an ongoing basis for any proposed design/material/process change or an observation in the field/service or manufacturing to determine the impact and need for any mitigation Come-up with the recommended mitigation with the rationale, Expedite, manage, and coordinate interrelated systems activities across functions, within the constraints of human and financial resources and changing priorities, Participate in identifying and planning tasks, activities, and resourcing needs related to systems engineering, Facilitate an improved understanding of the interrelationship between Requirements, Risk and Reliability, Working knowledge of FMEAs and standards applicable to Systems Engineering, Creates design concepts and research methodologies that best meet current and future customer & business needs for a product or process domain area, Understands clinical and user needs and is able to apply to product realization Creates and maintains Design History File elements, Successfully influences stakeholders and cross-functional team members within the project, Leverages knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a systems perspective, Leading labeling related verification activities, ensuring the manuals and other labeling deliverables are staying in compliance, Must possess sound knowledge of systems engineering disciplines and related areas like Electro-mechanical systems, A demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated products such as military hardware, Qualifications: Must possess sound knowledge of systems engineering disciplines and related areas like Electro-mechanical systems, A demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated products such as military hardware, Education and/or Experience: An engineering graduate in Electrical, Mechanical, Biomedical or related engineering discipline with 8-12 years of experience Prior experience in Medical/Acute device domain is a plus, Additional Duties and Responsibilities in case if the role is performing LSD Lead System Designer/ PDO Product Design Owner: Thorough understanding and drives application of phases of life cycle management, Ability to apply life cycle management principles across all phases of life cycle management, Initiates, develops and leads technical feasibility analysis for product or subsystems; translates customer/user needs to product needs, Proposes and drives solutions to complex technical problems that are ambiguous and diverse in scope, Drives adherence to FDA, ISO and IEC design control procedures, regulations and standards, Anticipates technical challenges and risk scenarios and prepares, leads, and executes mitigation strategies to ensure optimal results, Teaches and mentors others in life cycle management methodologies, Can perform as an independent reviewer in technical and design reviews, Gathers inputs for Requirements from various sources such as Standards, User needs, Regulatory, Quality, Human factors, Manufacturing, Service and so on Performs impacts assessment on the requirements on an ongoing basis for any proposed design/material/process change or an observation in the field/service or manufacturing to determine the impact and need for any mitigation Come-up with the recommended mitigation with the rationale, Facilitate an improved understanding of the interrelationship between Requirements, Risk and Reliability, Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice,