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
