13 Etq Jobs

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function Supply Chain Engineering Job Sub Function Manufacturing Engineering Job Category Scientific/Technology All Job Posting Locations: Aurangabad, Maharashtra, India Job Description SECTION 1: JOB SUMMARY* Design, execution and documentation of process characterization, process development, equipment qualification, validations, Manufacturing Equipment and Sterilization Validation Master Plan, and test methods used in manufacturing processes in the context of the applicable standards and regulations. Lead- Process Engineering is responsible to execute process engineering deliverables as per the engineering and base business strategies and objectives at the Aurangabad site. Ensures flawless execution of Manufacturing process validations or qualifications. Provides leadership to the Process team and ensures the support from all engineering functions and also other required cross functions. Responsible to ensure the integration with the regional and WW process engineering organization. Responsible to develop and execute the Sterilization strategies and objectives at ETHICON, Aurangabad site. Provides the leadership & support to engineering function for execution of EO and GAMMA sterilization projects and regular maintenance. Provide Technical knowledge to the Manufacturing engineering, Process engineering and Engineering Projects team. Designs, develops, tests, and evaluates new and existing manufacturing systems for industrial production processes including human work factors, material flow, cost analysis, and process optimization in both production and packaging operations which includes but not limited to Technology Roadmap projects. Is responsible for the Process Safety Management activities for the site. SECTION 2: DUTIES & RESPONSIBILITIES* Ensures coordination and execution of the recurring validation activities according to validation master plan. Leads cross functional teams (internal and external to engineering) and resolves inter- functional issues. Establishes and communicates process and program schedules, objectives, priorities, and targets. Ensures the documentation of project and program activities and deliverables. Planning, coordination, monitoring and evaluation of manufacturing equipment & process validation activities. Training of employees in validation specifications, test plans, test methods, etc. Supporting the selection of processes / machines, taking into account the requirements of project and production as well as investment and cost aspects. Ensuring an effective process risk management (FMEA) carrying out process risk analysis process participation in product risk analysis. Developing manufacturing processes under application / taking into account methodological concepts (Six Sigma, Lean). Supporting the root cause identification and implementation/documentation of corrective measures during the stabilization phase of a product / process development project. Taking over of co-ordination and project management tasks for the Aurangabad site if no project manager is associated with the project. Ensuring process optimization within the stabilization phase of a assigned project Engages to comply with ISO and FDA requirements. Ensuring compliance to the Quality system requirements. Utilizing problem solving skills and statistical techniques to support product / processes controls that are aligned with the overall quality and business vision. Assuring that engineering department is appropriately run in a safe, clean, and environmentally sound manner. Developing and analyzing statistical data and machine specification to determine present standards and establish proposed quality and reliability expectancy of finished product. Assisting in engineering budget preparation, goal tracking and in the business planning process. Supporting for NCR’s investigation and performs trend analysis and report to Management. Ensuring for training / compliance of GMP as per FDA guidelines and site procedures and Policies and on the job training. Participating in audits and gap assessments in support of the internal audit program and FDA readiness. Partnering with operations in the investigation / correction of process failure Developing safety culture in the engineering function. Prepares capital expenditure proposals starting from preparation of draft proposals, vendor selection, price negotiations, planning, and execution. Leads projects end-to-end. Lead engineering projects, New Technology or Technology Transfer projects to improve existing technology with respect to Quality, Compliance, Capacity and Cost. Ensure that projects are completed on time and within budget with no impact to quality or customer service. Develop and execute detailed project plans using standard project management tools (charter, Gantt chart, etc.). Prepare/review capital & expense forecasts for assigned projects. Prepare capital authorization requests (CAR). Sterilization: Under limited supervision & general direction and in accordance with all applicable federal, state and local laws/ regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: Prioritize, assign and coordinate for EO & Gamma sterilization, UDI, serialization and related work. Establish, review and communicate plans (work/project scope, cost, schedule, resource requirements, and risks) for sterilization related activities required to meet system demands and business objectives. Lead & prepare a sterilization road map and prepare a strategy to implement them. Support in preparing technology road map and prepare a strategy to implement them. Lead the various sterilization related projects in tandem with WW sterilization experts. Lead & deliver projects like sterilizer replacement, new cycle creation, existing cycle improvement (as needed) and new practices development. Monitor progress to ensure final deliverable meet lifecycle boundaries and customer acceptance criteria. Engage to comply with ISO and local FDA requirements. Responsible for revision I creation of documents like SOP, Forms etc. required for manufacturing /Sterilization/UDI/Serialization & as required. AUTHORITIES Create PR in emp/Ariba. Create & Approve PR in emp/Ariba Create/Approve Gate Pass for material. Change Assessment creation in ADAPTIV/ PLM system. CO/CP creation in ADAPTIV/PLM system. QMS document Approval creation/Approval in ADAPTIV/ PLM system. SECTION 3: EXPERIENCE AND EDUCATION* Bachelor’s degree with minimum 10 to 12 years of experience in Engineering/Industrial/Electrical/Mechanical Engineering (related stream). Experience in the Medical Device industry or pharmaceutical or consumer or similar industry with experience in aseptic handling. Demonstrated knowledge of manufacturing principles and practices and procedures. Knowledge of specific business practices and software and software applications. Experience using medical device equipment. Ability to communicate effectively with a diverse client/stakeholder base. Ability to work cooperatively with coworkers, peers and required stakeholders. Ability to perform duties in accordance with policies and procedures. SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS * Functional Competencies - Engineering Basics: Ability to use knowledge of technical designs, Understanding and creating Engineering drawings and leads key site projects/base business automation initiatives. Manufacturing processes Knowledge: Displays in-depth knowledge of manufacturing methods and standards of process control. Leverages the knowledge and leads practices to implement sustainable process improvements in assigned areas. Product knowledge: Understanding of Product functionalities and identifies improvement opportunities. Understand product requirements and translate into product characteristics and procedures. Ability to define, measure, improve product characteristics and their co-relation with product performance. Process Excellence: Displays in-depth understanding of Lean tools & techniques, Value stream mapping, Six Sigma as a certified Black Belt, Statistical Data Analysis & process controls. Technical Quality and Compliance: Displays in-depth knowledge of J&J quality standards to implement cross-functional corrective action related to quality issues. Use in-depth knowledge of EHS policies to guide others when implementing EHS initiatives. Standard Cost generation: Displays in-depth Knowledge within Financial Systems and Budget Preparation, ROI calculation, standard cost planning and leverages the skills and leading Practices to implement long range business plans that meet J&J strategic Goals & creates new opportunities. Image/Signal Processing and Robotics: Displays in-depth Knowledge within image analysis, image processing, image algorithms, robotic systems, software and verification systems development and leverages the skills and leading Practices to implement processing strategy. Mechanical Equipment & Systems: Displays in-depth knowledge of commissioning of mechanical equipment, Safety equipment and leverages best practices. Process Validations: Ability to develop/plan qualification strategy for overall process, execution of strategy and plans in a diligent manner; ability to react/resolve issues that occur during qualifications; basic knowledge of statistical techniques. Packaging Equipment and Operation: Consistently applies Knowledge and experience to a wide variety of activities and situations associated with Automation & Robotics, Vacuum Technology, Programmable Logic Controllers (PLC), Mechanical Engineering, Sterilization/Cleanroom Technology. Packaging Process: Consistently applies Knowledge and experience to a wide variety of activities and situations associated with Packaging Process, Packaging Materials, Test Methods, Packaging Classification & Types. Packaging Design: Displays in-depth Knowledge within Develops & Implements New Technology concepts and methods and leverages the skills and leading Practices to implement long range business plans that meet J&J strategic Goals & creates new opportunities. Professional Competencies- Analytical Problem Solving: Applies understanding of analytic techniques to interpret data, identify issues, analyze causes of the issues, and provide well-reasoned conclusions and solutions. Technology & Data Management: Uses in-depth knowledge of system and technology capabilities, architecture, and leading practices to effectively interface with IT professionals to identify, select, and implement tools that enable business processes. Quality Mindset: Participates in quality processes, as appropriate, including validation and compliance- related issues (for example, FDA regulations, holds, customs, etc.) Demonstrates an understanding of the critical importance of traceability and ability to apply supporting approaches or technologies (i.e. lot coding, expiration dating, etc.) Applies knowledge of validation strategies and/or continuous improvement concepts to proactively identify process deficiencies or improvements. Analytical Problem solving: Uses in-depth knowledge of analysis and problem-solving techniques to study reports, identify underlying issues or trends, and assess broader implications of the findings, based upon the interpretation of quantifiable data, to recommend appropriate solutions. Project Management: Demonstrates expertise in project management tools and techniques, interactions with project stakeholders and sponsors. Identifies innovative ways to improve cost or lead-time to maximize resources to achieve project outcomes. Leverages understanding of FPX and other project management methodologies to perform root-cause analysis on project failures. Business Case Development: Uses in-depth knowledge of business case development to articulate the business case for broad, cross-departmental change to decision-makers Mentors others by providing direction and context for change by outlining linkages between functional activities and J&J’s bottom line. Knowledge of project management methodologies (e.g., PMP etc.) Knowledge of continuous improvement tools, Lean Manufacturing & Six- Sigma. Ability to lead a team of professionals with diverse skills and competencies spanning business & technical areas. Knowledge of SAP based MRP, Visio, MS Project, Minitab, ADAPTIV, ETQ Audit, ETQ CAPA, ETQ NC & Compliance Wire. Show more Show less

Function Supply Chain Engineering Sub function Manufacturing Engineering Category Senior Engineer, Manufacturing Engineering (ST6) Location Aurangabad / India Date posted Jun 16 2025 Requisition number R-016531 Work pattern Fully Onsite Description At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Supply Chain Engineering Job Sub Function: Manufacturing Engineering Job Category: Scientific/Technology All Job Posting Locations: Aurangabad, Maharashtra, India Job Description: SECTION 1: JOB SUMMARY* Design, execution and documentation of process characterization, process development, equipment qualification, validations, Manufacturing Equipment and Sterilization Validation Master Plan, and test methods used in manufacturing processes in the context of the applicable standards and regulations. Lead- Process Engineering is responsible to execute process engineering deliverables as per the engineering and base business strategies and objectives at the Aurangabad site. Ensures flawless execution of Manufacturing process validations or qualifications. Provides leadership to the Process team and ensures the support from all engineering functions and also other required cross functions. Responsible to ensure the integration with the regional and WW process engineering organization. Responsible to develop and execute the Sterilization strategies and objectives at ETHICON, Aurangabad site. Provides the leadership & support to engineering function for execution of EO and GAMMA sterilization projects and regular maintenance. Provide Technical knowledge to the Manufacturing engineering, Process engineering and Engineering Projects team. Designs, develops, tests, and evaluates new and existing manufacturing systems for industrial production processes including human work factors, material flow, cost analysis, and process optimization in both production and packaging operations which includes but not limited to Technology Roadmap projects. Is responsible for the Process Safety Management activities for the site. SECTION 2: DUTIES & RESPONSIBILITIES* Ensures coordination and execution of the recurring validation activities according to validation master plan. Leads cross functional teams (internal and external to engineering) and resolves inter- functional issues. Establishes and communicates process and program schedules, objectives, priorities, and targets. Ensures the documentation of project and program activities and deliverables. Planning, coordination, monitoring and evaluation of manufacturing equipment & process validation activities. Training of employees in validation specifications, test plans, test methods, etc. Supporting the selection of processes / machines, taking into account the requirements of project and production as well as investment and cost aspects. Ensuring an effective process risk management (FMEA) carrying out process risk analysis process participation in product risk analysis. Developing manufacturing processes under application / taking into account methodological concepts (Six Sigma, Lean). Supporting the root cause identification and implementation/documentation of corrective measures during the stabilization phase of a product / process development project. Taking over of co-ordination and project management tasks for the Aurangabad site if no project manager is associated with the project. Ensuring process optimization within the stabilization phase of a assigned project Engages to comply with ISO and FDA requirements. Ensuring compliance to the Quality system requirements. Utilizing problem solving skills and statistical techniques to support product / processes controls that are aligned with the overall quality and business vision. Assuring that engineering department is appropriately run in a safe, clean, and environmentally sound manner. Developing and analyzing statistical data and machine specification to determine present standards and establish proposed quality and reliability expectancy of finished product. Assisting in engineering budget preparation, goal tracking and in the business planning process. Supporting for NCR’s investigation and performs trend analysis and report to Management. Ensuring for training / compliance of GMP as per FDA guidelines and site procedures and Policies and on the job training. Participating in audits and gap assessments in support of the internal audit program and FDA readiness. Partnering with operations in the investigation / correction of process failure Developing safety culture in the engineering function. Prepares capital expenditure proposals starting from preparation of draft proposals, vendor selection, price negotiations, planning, and execution. Leads projects end-to-end. Lead engineering projects, New Technology or Technology Transfer projects to improve existing technology with respect to Quality, Compliance, Capacity and Cost. Ensure that projects are completed on time and within budget with no impact to quality or customer service. Develop and execute detailed project plans using standard project management tools (charter, Gantt chart, etc.). Prepare/review capital & expense forecasts for assigned projects. Prepare capital authorization requests (CAR). Sterilization: Under limited supervision & general direction and in accordance with all applicable federal, state and local laws/ regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: Prioritize, assign and coordinate for EO & Gamma sterilization, UDI, serialization and related work. Establish, review and communicate plans (work/project scope, cost, schedule, resource requirements, and risks) for sterilization related activities required to meet system demands and business objectives. Lead & prepare a sterilization road map and prepare a strategy to implement them. Support in preparing technology road map and prepare a strategy to implement them. Lead the various sterilization related projects in tandem with WW sterilization experts. Lead & deliver projects like sterilizer replacement, new cycle creation, existing cycle improvement (as needed) and new practices development. Monitor progress to ensure final deliverable meet lifecycle boundaries and customer acceptance criteria. Engage to comply with ISO and local FDA requirements. Responsible for revision I creation of documents like SOP, Forms etc. required for manufacturing /Sterilization/UDI/Serialization & as required. AUTHORITIES Create PR in emp/Ariba. Create & Approve PR in emp/Ariba Create/Approve Gate Pass for material. Change Assessment creation in ADAPTIV/ PLM system. CO/CP creation in ADAPTIV/PLM system. QMS document Approval creation/Approval in ADAPTIV/ PLM system. SECTION 3: EXPERIENCE AND EDUCATION* Bachelor’s degree with minimum 10 to 12 years of experience in Engineering/Industrial/Electrical/Mechanical Engineering (related stream). Experience in the Medical Device industry or pharmaceutical or consumer or similar industry with experience in aseptic handling. Demonstrated knowledge of manufacturing principles and practices and procedures. Knowledge of specific business practices and software and software applications. Experience using medical device equipment. Ability to communicate effectively with a diverse client/stakeholder base. Ability to work cooperatively with coworkers, peers and required stakeholders. Ability to perform duties in accordance with policies and procedures. SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS * Functional Competencies - Engineering Basics: Ability to use knowledge of technical designs, Understanding and creating Engineering drawings and leads key site projects/base business automation initiatives. Manufacturing processes Knowledge: Displays in-depth knowledge of manufacturing methods and standards of process control. Leverages the knowledge and leads practices to implement sustainable process improvements in assigned areas. Product knowledge: Understanding of Product functionalities and identifies improvement opportunities. Understand product requirements and translate into product characteristics and procedures. Ability to define, measure, improve product characteristics and their co-relation with product performance. Process Excellence: Displays in-depth understanding of Lean tools & techniques, Value stream mapping, Six Sigma as a certified Black Belt, Statistical Data Analysis & process controls. Technical Quality and Compliance: Displays in-depth knowledge of J&J quality standards to implement cross-functional corrective action related to quality issues. Use in-depth knowledge of EHS policies to guide others when implementing EHS initiatives. Standard Cost generation: Displays in-depth Knowledge within Financial Systems and Budget Preparation, ROI calculation, standard cost planning and leverages the skills and leading Practices to implement long range business plans that meet J&J strategic Goals & creates new opportunities. Image/Signal Processing and Robotics: Displays in-depth Knowledge within image analysis, image processing, image algorithms, robotic systems, software and verification systems development and leverages the skills and leading Practices to implement processing strategy. Mechanical Equipment & Systems: Displays in-depth knowledge of commissioning of mechanical equipment, Safety equipment and leverages best practices. Process Validations: Ability to develop/plan qualification strategy for overall process, execution of strategy and plans in a diligent manner; ability to react/resolve issues that occur during qualifications; basic knowledge of statistical techniques. Packaging Equipment and Operation: Consistently applies Knowledge and experience to a wide variety of activities and situations associated with Automation & Robotics, Vacuum Technology, Programmable Logic Controllers (PLC), Mechanical Engineering, Sterilization/Cleanroom Technology. Packaging Process: Consistently applies Knowledge and experience to a wide variety of activities and situations associated with Packaging Process, Packaging Materials, Test Methods, Packaging Classification & Types. Packaging Design: Displays in-depth Knowledge within Develops & Implements New Technology concepts and methods and leverages the skills and leading Practices to implement long range business plans that meet J&J strategic Goals & creates new opportunities. Professional Competencies- Analytical Problem Solving: Applies understanding of analytic techniques to interpret data, identify issues, analyze causes of the issues, and provide well-reasoned conclusions and solutions. Technology & Data Management: Uses in-depth knowledge of system and technology capabilities, architecture, and leading practices to effectively interface with IT professionals to identify, select, and implement tools that enable business processes. Quality Mindset: Participates in quality processes, as appropriate, including validation and compliance- related issues (for example, FDA regulations, holds, customs, etc.) Demonstrates an understanding of the critical importance of traceability and ability to apply supporting approaches or technologies (i.e. lot coding, expiration dating, etc.) Applies knowledge of validation strategies and/or continuous improvement concepts to proactively identify process deficiencies or improvements. Analytical Problem solving: Uses in-depth knowledge of analysis and problem-solving techniques to study reports, identify underlying issues or trends, and assess broader implications of the findings, based upon the interpretation of quantifiable data, to recommend appropriate solutions. Project Management: Demonstrates expertise in project management tools and techniques, interactions with project stakeholders and sponsors. Identifies innovative ways to improve cost or lead-time to maximize resources to achieve project outcomes. Leverages understanding of FPX and other project management methodologies to perform root-cause analysis on project failures. Business Case Development: Uses in-depth knowledge of business case development to articulate the business case for broad, cross-departmental change to decision-makers Mentors others by providing direction and context for change by outlining linkages between functional activities and J&J’s bottom line. Knowledge of project management methodologies (e.g., PMP etc.) Knowledge of continuous improvement tools, Lean Manufacturing & Six- Sigma. Ability to lead a team of professionals with diverse skills and competencies spanning business & technical areas. Knowledge of SAP based MRP, Visio, MS Project, Minitab, ADAPTIV, ETQ Audit, ETQ CAPA, ETQ NC & Compliance Wire.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Supply Chain Engineering Job Sub Function: Manufacturing Engineering Job Category: Scientific/Technology All Job Posting Locations: Aurangabad, Maharashtra, India Job Description: SECTION 1: JOB SUMMARY* Design, execution and documentation of process characterization, process development, equipment qualification, validations, Manufacturing Equipment and Sterilization Validation Master Plan, and test methods used in manufacturing processes in the context of the applicable standards and regulations. Lead- Process Engineering is responsible to execute process engineering deliverables as per the engineering and base business strategies and objectives at the Aurangabad site. Ensures flawless execution of Manufacturing process validations or qualifications. Provides leadership to the Process team and ensures the support from all engineering functions and also other required cross functions. Responsible to ensure the integration with the regional and WW process engineering organization. Responsible to develop and execute the Sterilization strategies and objectives at ETHICON, Aurangabad site. Provides the leadership & support to engineering function for execution of EO and GAMMA sterilization projects and regular maintenance. Provide Technical knowledge to the Manufacturing engineering, Process engineering and Engineering Projects team. Designs, develops, tests, and evaluates new and existing manufacturing systems for industrial production processes including human work factors, material flow, cost analysis, and process optimization in both production and packaging operations which includes but not limited to Technology Roadmap projects. Is responsible for the Process Safety Management activities for the site. SECTION 2: DUTIES & RESPONSIBILITIES* Ensures coordination and execution of the recurring validation activities according to validation master plan. Leads cross functional teams (internal and external to engineering) and resolves inter- functional issues. Establishes and communicates process and program schedules, objectives, priorities, and targets. Ensures the documentation of project and program activities and deliverables. Planning, coordination, monitoring and evaluation of manufacturing equipment & process validation activities. Training of employees in validation specifications, test plans, test methods, etc. Supporting the selection of processes / machines, taking into account the requirements of project and production as well as investment and cost aspects. Ensuring an effective process risk management (FMEA) carrying out process risk analysis process participation in product risk analysis. Developing manufacturing processes under application / taking into account methodological concepts (Six Sigma, Lean). Supporting the root cause identification and implementation/documentation of corrective measures during the stabilization phase of a product / process development project. Taking over of co-ordination and project management tasks for the Aurangabad site if no project manager is associated with the project. Ensuring process optimization within the stabilization phase of a assigned project Engages to comply with ISO and FDA requirements. Ensuring compliance to the Quality system requirements. Utilizing problem solving skills and statistical techniques to support product / processes controls that are aligned with the overall quality and business vision. Assuring that engineering department is appropriately run in a safe, clean, and environmentally sound manner. Developing and analyzing statistical data and machine specification to determine present standards and establish proposed quality and reliability expectancy of finished product. Assisting in engineering budget preparation, goal tracking and in the business planning process. Supporting for NCR’s investigation and performs trend analysis and report to Management. Ensuring for training / compliance of GMP as per FDA guidelines and site procedures and Policies and on the job training. Participating in audits and gap assessments in support of the internal audit program and FDA readiness. Partnering with operations in the investigation / correction of process failure Developing safety culture in the engineering function. Prepares capital expenditure proposals starting from preparation of draft proposals, vendor selection, price negotiations, planning, and execution. Leads projects end-to-end. Lead engineering projects, New Technology or Technology Transfer projects to improve existing technology with respect to Quality, Compliance, Capacity and Cost. Ensure that projects are completed on time and within budget with no impact to quality or customer service. Develop and execute detailed project plans using standard project management tools (charter, Gantt chart, etc.). Prepare/review capital & expense forecasts for assigned projects. Prepare capital authorization requests (CAR). Sterilization: Under limited supervision & general direction and in accordance with all applicable federal, state and local laws/ regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: Prioritize, assign and coordinate for EO & Gamma sterilization, UDI, serialization and related work. Establish, review and communicate plans (work/project scope, cost, schedule, resource requirements, and risks) for sterilization related activities required to meet system demands and business objectives. Lead & prepare a sterilization road map and prepare a strategy to implement them. Support in preparing technology road map and prepare a strategy to implement them. Lead the various sterilization related projects in tandem with WW sterilization experts. Lead & deliver projects like sterilizer replacement, new cycle creation, existing cycle improvement (as needed) and new practices development. Monitor progress to ensure final deliverable meet lifecycle boundaries and customer acceptance criteria. Engage to comply with ISO and local FDA requirements. Responsible for revision I creation of documents like SOP, Forms etc. required for manufacturing /Sterilization/UDI/Serialization & as required. AUTHORITIES Create PR in emp/Ariba. Create & Approve PR in emp/Ariba Create/Approve Gate Pass for material. Change Assessment creation in ADAPTIV/ PLM system. CO/CP creation in ADAPTIV/PLM system. QMS document Approval creation/Approval in ADAPTIV/ PLM system. SECTION 3: EXPERIENCE AND EDUCATION* Bachelor’s degree with minimum 10 to 12 years of experience in Engineering/Industrial/Electrical/Mechanical Engineering (related stream). Experience in the Medical Device industry or pharmaceutical or consumer or similar industry with experience in aseptic handling. Demonstrated knowledge of manufacturing principles and practices and procedures. Knowledge of specific business practices and software and software applications. Experience using medical device equipment. Ability to communicate effectively with a diverse client/stakeholder base. Ability to work cooperatively with coworkers, peers and required stakeholders. Ability to perform duties in accordance with policies and procedures. SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS * Functional Competencies - Engineering Basics: Ability to use knowledge of technical designs, Understanding and creating Engineering drawings and leads key site projects/base business automation initiatives. Manufacturing processes Knowledge: Displays in-depth knowledge of manufacturing methods and standards of process control. Leverages the knowledge and leads practices to implement sustainable process improvements in assigned areas. Product knowledge: Understanding of Product functionalities and identifies improvement opportunities. Understand product requirements and translate into product characteristics and procedures. Ability to define, measure, improve product characteristics and their co-relation with product performance. Process Excellence: Displays in-depth understanding of Lean tools & techniques, Value stream mapping, Six Sigma as a certified Black Belt, Statistical Data Analysis & process controls. Technical Quality and Compliance: Displays in-depth knowledge of J&J quality standards to implement cross-functional corrective action related to quality issues. Use in-depth knowledge of EHS policies to guide others when implementing EHS initiatives. Standard Cost generation: Displays in-depth Knowledge within Financial Systems and Budget Preparation, ROI calculation, standard cost planning and leverages the skills and leading Practices to implement long range business plans that meet J&J strategic Goals & creates new opportunities. Image/Signal Processing and Robotics: Displays in-depth Knowledge within image analysis, image processing, image algorithms, robotic systems, software and verification systems development and leverages the skills and leading Practices to implement processing strategy. Mechanical Equipment & Systems: Displays in-depth knowledge of commissioning of mechanical equipment, Safety equipment and leverages best practices. Process Validations: Ability to develop/plan qualification strategy for overall process, execution of strategy and plans in a diligent manner; ability to react/resolve issues that occur during qualifications; basic knowledge of statistical techniques. Packaging Equipment and Operation: Consistently applies Knowledge and experience to a wide variety of activities and situations associated with Automation & Robotics, Vacuum Technology, Programmable Logic Controllers (PLC), Mechanical Engineering, Sterilization/Cleanroom Technology. Packaging Process: Consistently applies Knowledge and experience to a wide variety of activities and situations associated with Packaging Process, Packaging Materials, Test Methods, Packaging Classification & Types. Packaging Design: Displays in-depth Knowledge within Develops & Implements New Technology concepts and methods and leverages the skills and leading Practices to implement long range business plans that meet J&J strategic Goals & creates new opportunities. Professional Competencies- Analytical Problem Solving: Applies understanding of analytic techniques to interpret data, identify issues, analyze causes of the issues, and provide well-reasoned conclusions and solutions. Technology & Data Management: Uses in-depth knowledge of system and technology capabilities, architecture, and leading practices to effectively interface with IT professionals to identify, select, and implement tools that enable business processes. Quality Mindset: Participates in quality processes, as appropriate, including validation and compliance- related issues (for example, FDA regulations, holds, customs, etc.) Demonstrates an understanding of the critical importance of traceability and ability to apply supporting approaches or technologies (i.e. lot coding, expiration dating, etc.) Applies knowledge of validation strategies and/or continuous improvement concepts to proactively identify process deficiencies or improvements. Analytical Problem solving: Uses in-depth knowledge of analysis and problem-solving techniques to study reports, identify underlying issues or trends, and assess broader implications of the findings, based upon the interpretation of quantifiable data, to recommend appropriate solutions. Project Management: Demonstrates expertise in project management tools and techniques, interactions with project stakeholders and sponsors. Identifies innovative ways to improve cost or lead-time to maximize resources to achieve project outcomes. Leverages understanding of FPX and other project management methodologies to perform root-cause analysis on project failures. Business Case Development: Uses in-depth knowledge of business case development to articulate the business case for broad, cross-departmental change to decision-makers Mentors others by providing direction and context for change by outlining linkages between functional activities and J&J’s bottom line. Knowledge of project management methodologies (e.g., PMP etc.) Knowledge of continuous improvement tools, Lean Manufacturing & Six- Sigma. Ability to lead a team of professionals with diverse skills and competencies spanning business & technical areas. Knowledge of SAP based MRP, Visio, MS Project, Minitab, ADAPTIV, ETQ Audit, ETQ CAPA, ETQ NC & Compliance Wire.

Role- ETQ Developer Job Description Roles & Responsibilities Participating in business requirement discussions and providing key technical inputs Leading the technical deliverables Directly handling technical queries from customer Managing day to day relationships with customer, technical team, vendor team, upstream / downstream application team, quality assurance team, testing team and other stake holders to ensure the completeness, correctness and quality of solution delivered to the customer Working towards project deadlines Leading the technical communications across teams Collaborating with project teams in other parts of the world Ability to deliver right from the first day

YASH Technologies is a leading technology integrator specializing in helping clients reimagine operating models, enhance competitiveness, optimize costs, foster exceptional stakeholder experiences, and drive business transformation. At YASH, we’re a cluster of the brightest stars working with cutting-edge technologies. Our purpose is anchored in a single truth – bringing real positive changes in an increasingly virtual world and it drives us beyond generational gaps and disruptions of the future. We are looking forward to hire Azure Integration Professionals in the following areas : We are seeking a highly skilled Senior Azure Integration Developer to lead the design, development, and deployment of robust integration solutions using Microsoft Azure. This role focuses on integrating Azure Integration Services , and third-party enterprise applications (such as SAP , ETQ , and custom .NET APIs**). The ideal candidate will possess deep knowledge of Azure services , and integration architecture patterns , and will be responsible for building cloud-native, scalable, and secure enterprise solutions. Key Responsibilities Architect and implement enterprise integration solutions using Azure services such as: Azure Functions Azure Logic Apps Azure API Management (APIM) Azure Service Bus / Event Grid Azure Data Factory (for data orchestration) Design and develop Applications with custom HTTP connectors to integrate with external APIs (e.g., .NET, ETQ). Integrate with SAP and ETQ systems using custom APIs for modules like Suppliers, Materials, CAPA, SCAR, Deviation, and Non-Confirmation. Manage Azure Active Directory (AAD) for secure authentication and role-based access. Handle large-scale data processing using Azure Blob Storage, Asynchronous Web Jobs, and Azure SQL Database. Build and maintain custom connectors in Power Platform for reusable integrations. Implement pagination and optimized grid views in PowerApps for handling >2000 records efficiently. Enable notifications and alerts through Azure Functions and third-party messaging/email services. Establish and maintain CI/CD pipelines using Azure DevOps for automated deployment. Apply Infrastructure as Code (IaC) practices using ARM templates or Bicep. Implement robust logging, monitoring, and error handling for all integration components. Collaborate with architects, analysts, and developers to understand business requirements and deliver technical solutions. Provide technical leadership and mentorship to junior developers and promote best practices. Required Skills & Experience: 3+ years of experience in Azure development and integration solutions. Deep expertise in Azure Integration Services (Functions, Logic Apps, APIM, Service Bus). Strong understanding of RESTful APIs, HTTP, JSON, and API security. Experience with Azure SQL Database, Blob Storage, and asynchronous data processing. Background in integrating with SAP, ETQ, and .NET-based enterprise systems. Familiarity with AAD, RBAC, and enterprise-grade authentication mechanisms. Hands-on experience in CI/CD, IaC, and automated deployment pipelines. Strong problem-solving, debugging, and performance tuning skills. Preferred Qualifications: Microsoft Certified: Azure Developer Associate, Power Platform Developer Associate, or Azure Solutions Architect. Experience with enterprise recall applications, quality systems, or regulated environments. Knowledge of ETL, data transformation, and master data management practices. Exposure to Agile/Scrum methodologies and tools like Jira or Azure Boards. At YASH, you are empowered to create a career that will take you to where you want to go while working in an inclusive team environment. We leverage career-oriented skilling models and optimize our collective intelligence aided with technology for continuous learning, unlearning, and relearning at a rapid pace and scale. Our Hyperlearning workplace is grounded upon four principles Flexible work arrangements, Free spirit, and emotional positivity Agile self-determination, trust, transparency, and open collaboration All Support needed for the realization of business goals, Stable employment with a great atmosphere and ethical corporate culture Show more Show less

Req ID: 123864 Remote Position: Hybrid Region: Asia Country: India State/Province: Chennai City: Guindy, Chennai Summary We are seeking a highly motivated and experienced Specialist Tester to join our dynamic Global Test Team within the IT Project Management Office. In this role, you will play a critical part in ensuring the quality and reliability of our application solutions across key platforms. You will be responsible for developing and executing comprehensive test cases, collaborating closely with project teams, and advocating for a customer-centric approach to testing. Detailed Description Performs tasks such as, but not limited to, the following: Test Planning & Execution: Analyze business requirements and technical specifications to design and develop detailed test cases, scenarios, and scripts. Execute functional, integration, regression, and performance testing across SAP, Digital Factory, PLM, and ETQ platforms. Utilize testing tools and methodologies to optimize testing efficiency and coverage. Document and track defects, working closely with development teams to ensure timely resolution. Collaboration & Communication: Collaborate effectively with project managers, business analysts, developers, and other stakeholders throughout the software development lifecycle. Provide clear and concise testing updates and reports to the project team and management. Actively participate in project meetings and contribute to testing-related discussions. Quality Assurance & Continuous Improvement: Advocate for quality throughout the project lifecycle, ensuring adherence to testing standards and best practices. Contribute to the development and improvement of testing processes and methodologies. Stay abreast of industry trends and emerging technologies in software testing. Knowledge/Skills/Competencies Extensive experience in testing SAP applications, including functional modules relevant to the organization (e.g. SD, MM, WM, PP, QM, FICO). Solid understanding of PLM concepts and experience in testing PLM platforms (e.g. Enovia 3DEXperience or equivalent). Hands-on experience with testing in-house developed Manufacturing Execution Systems (MES), including its integration with the shop floor systems. Familiarity with ETQ Reliance or similar quality management systems. Strong knowledge of software testing methodologies, including Agile and Waterfall. Experience with test management tools (e.g., HP ALM, Jira). Excellent analytical, problem-solving, and communication skills. Physical Demands Duties of this position are performed in a normal office environment. Duties may require extended periods of sitting and sustained visual concentration on a computer monitor or on numbers and other detailed data. Repetitive manual movements (e.g., data entry, using a computer mouse, using a calculator, etc.) are frequently required. Typical Experience 5+ years of proven experience in software testing, with a strong focus on business process testing. Typical Education Bachelor’s degree in Computer Science, Information Technology, or a related field. Notes This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time. Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status or other characteristics protected by law). At Celestica we are committed to fostering an inclusive, accessible environment, where all employees and customers feel valued, respected and supported. Special arrangements can be made for candidates who need it throughout the hiring process. Please indicate your needs and we will work with you to meet them. Company Overview Celestica (NYSE, TSX: CLS) enables the world’s best brands. Through our recognized customer-centric approach, we partner with leading companies in Aerospace and Defense, Communications, Enterprise, HealthTech, Industrial, Capital Equipment and Energy to deliver solutions for their most complex challenges. As a leader in design, manufacturing, hardware platform and supply chain solutions, Celestica brings global expertise and insight at every stage of product development – from drawing board to full-scale production and after-market services for products from advanced medical devices, to highly engineered aviation systems, to next-generation hardware platform solutions for the Cloud. Headquartered in Toronto, with talented teams spanning 40+ locations in 13 countries across the Americas, Europe and Asia, we imagine, develop and deliver a better future with our customers. Celestica would like to thank all applicants, however, only qualified applicants will be contacted. Celestica does not accept unsolicited resumes from recruitment agencies or fee based recruitment services. Show more Show less

About the Company Newen Systems is India’s leading power conversion and energy storage solutions provider, driving energy transition and grid stability. Newen’s state of the art manufacturing facilities at Vadodara is at the heart of driving innovation and GW scale energy revolution for the world. With 3,000+ MW of battery storage deployed across 65+ countries in all seven continents, Newen Systems in technical collaboration with Dynapower is delivering BESS, Green H2, Microgrid and e-mobility infrastructure solutions to customers in India and around the world. Newen’s cutting edge energy management system is helping customers maximize their energy investment in ways it was not imagined earlier. Newen is uniquely positioned globally to provide EMS and PCS under one roof enabling customers to do integration tests within the factory rather than on site saving them time and money. As we expand, we are looking for intrapreneurial talent who have the passion to drive energy transition and deliver solutions to drive sustainability on a global scale. About the Role The Electrical Project Quality Engineer is responsible for ensuring that all electrical installations and systems meet the required quality standards and comply with applicable codes, standards, and project specifications. This role involves planning, implementing, and monitoring quality control procedures throughout the project lifecycle. Responsibilities Develop and implement project-specific Quality Plans, Inspection & Test Plans (ITPs), and checklists for electrical systems. Conduct inspections and tests on electrical installations including cable trays, wiring, panels, grounding, lighting, and control systems. Review and verify electrical drawings, specifications, and material submittals for compliance. Coordinate with construction teams, subcontractors, and suppliers to ensure quality standards are met. Monitor and document all quality control activities and maintain comprehensive records. Identify non-conformities, issue NCRs (Non-Conformance Reports), and ensure corrective actions are implemented. Participate in internal and external audits and support continuous improvement initiatives. Ensure compliance with safety regulations and electrical codes (e.g., NEC, IEC, IEEE). Provide technical support and training to site personnel on quality procedures and standards. Qualifications Bachelor’s degree in electrical/Electronic engineering or related field. Minimum 7 years of experience in electrical QA/QC roles within BESS or industrial projects. Strong knowledge of electrical systems, standards, and testing procedures. Excellent communication, documentation, and problem-solving skills. Required Skills Technical Skills: Electrical Engineering Knowledge: Strong understanding of electrical systems, components, and standards (e.g., IEC, NEC, IEEE). Quality Management Systems (QMS): Familiarity with ISO 9001 and other quality frameworks. Inspection & Testing: Proficiency in electrical testing methods (e.g., insulation resistance, continuity, voltage drop). Documentation & Reporting: Ability to prepare and manage ITPs, checklists, NCRs, and quality reports. Standards & Codes Compliance: Knowledge of national and international codes relevant to the project (e.g., MNRE, BIS for solar). Root Cause Analysis: Skills in identifying, analyzing, and resolving quality issues using tools like 5 Whys, Fishbone Diagram, etc. Analytical & Problem-Solving Skills: Attention to detail in identifying defects or deviations. Ability to interpret technical drawings and specifications. Strong troubleshooting skills for on-site quality issues. Tools & Software: MS Office Suite: Especially Excel and Word for documentation and reporting. AutoCAD / Electrical CAD: For reviewing and marking up drawings. Quality Management Software: Tools like SAP QM, ETQ, or custom project management platforms. Testing Equipment: Familiarity with multimeters, insulation testers, and other electrical QA tools. Show more Show less

Key Responsibilities: Architect and implement enterprise integration solutions using Azure services such as: Azure Functions Azure Logic Apps Azure API Management (APIM) Azure Service Bus / Event Grid Azure Data Factory (for data orchestration) Design and develop Applications with custom HTTP connectors to integrate with external APIs (e.g., .NET, ETQ). Integrate with SAP and ETQ systems using custom APIs for modules like Suppliers, Materials, CAPA, SCAR, Deviation, and Non-Confirmation. Manage Azure Active Directory (AAD) for secure authentication and role-based access. Handle large-scale data processing using Azure Blob Storage , Asynchronous Web Jobs , and Azure SQL Database . Build and maintain custom connectors in Power Platform for reusable integrations. Implement pagination and optimized grid views in PowerApps for handling >2000 records efficiently. Enable notifications and alerts through Azure Functions and third-party messaging/email services. Establish and maintain CI/CD pipelines using Azure DevOps for automated deployment. Apply Infrastructure as Code (IaC) practices using ARM templates or Bicep . Implement robust logging, monitoring, and error handling for all integration components. Collaborate with architects, analysts, and developers to understand business requirements and deliver technical solutions. Provide technical leadership and mentorship to junior developers and promote best practices. Required Skills & Experience: 3+ years of experience in Azure development and integration solutions . Deep expertise in Azure Integration Services (Functions, Logic Apps, APIM, Service Bus). Strong understanding of RESTful APIs , HTTP , JSON , and API security . Experience with Azure SQL Database , Blob Storage , and asynchronous data processing. Background in integrating with SAP , ETQ , and .NET-based enterprise systems . Familiarity with AAD , RBAC , and enterprise-grade authentication mechanisms. Hands-on experience in CI/CD , IaC , and automated deployment pipelines. Strong problem-solving, debugging, and performance tuning skills. Preferred Qualifications: Microsoft Certified : Azure Developer Associate, Power Platform Developer Associate, or Azure Solutions Architect. Experience with enterprise recall applications , quality systems , or regulated environments . Knowledge of ETL , data transformation , and master data management practices. Exposure to Agile/Scrum methodologies and tools like Jira or Azure Boards . Show more Show less

Responsibilities Manage day-to-day operational aspects and scope of assigned projects. Review deliverables prepared by team before sharing with client. Facilitate team and client meetings. Resolve and/or escalate issues in a timely fashion with guidance from the Senior Implementation Consultant. Ensure project documents follow standards and are complete, current and stored appropriately. Create and execute project work plans and revise as appropriate to meet changing needs and requirments Perform requirements gathering, Design Specification creation and configuration as needed as part of all services projects. Specifically, cover application configuration, usage and model fit for existing business processes Propose and configure application solutions to meet defined processes. Effectively communicate relevant project information to superiors and executives. Enter daily timesheets to account for all the billable work on projects. Respond to customer and internal questions regarding ETQ product features and implementation. Perform regular customer follow-ups until the customer has implemented their application. Collaborate with Customer Service as needed on long-term follow-ups. Review the release notes and manuals for new releases and get self-trained. Perform presentations/projects as defined by Professional Services Leadership. Education / Qualifications Bachelor’s degree in computer science or equivalent work experience. Strong analytical and problem-solving skills. Experience with scripting or programming languages, Python preferred. Understanding of relational databases and ability to create SQL queries (intermediate level). Understanding and exposure to web UI technologies, including HTML, CSS, and JavaScript. Understanding of object-oriented programming Experience working in an agile environment, Scrum preferred. Experience in the Quality Management / Environmental Health & Safety domain a PLUS. Familiarity with Java a PLUS About Hexagon Hexagon is a global leader in digital reality solutions, combining sensor, software and autonomous technologies. We are putting data to work to boost efficiency, productivity, quality and safety across industrial, manufacturing, infrastructure, public sector, and mobility applications. Hexagon’s Asset Lifecycle Intelligence division helps clients design, construct, and operate more profitable, safe, and sustainable industrial facilities. We empower customers to unlock data, accelerate industrial project modernization and digital maturity, increase productivity, and move the sustainability needle. Our technologies help produce actionable insights that enable better decision-making and intelligence across the asset lifecycle of industrial projects, leading to improvements in safety, quality, efficiency, and productivity, which contribute to Economic and Environmental Sustainability. Hexagon (Nasdaq Stockholm: HEXA B) has approximately 25,000 employees in 50 countries and net sales of approximately 5.4bn EUR. Learn more at hexagon.com and follow us @HexagonAB. Why work for Hexagon? At Hexagon, if you can see it, you can do it. Hexagon’s Asset Lifecyle Intelligence division puts their trust in you so that you can bring your ideas to life. We have emerged as one of the most engaged and enabled workplaces*. We are committed to creating an environment that is truly supportive by providing the resources you need to fully support your ambitions, no matter who you are or where you are in the world. In the recently concluded workplace effectiveness survey by Korn Ferry, a global HR advisory firm, Hexagon, Asset Lifecycle Intelligence division has emerged as one of the most Engaged and Enabled workplaces, when compared to similar organizations that Korn Ferry partners with. Everyone is welcome At Hexagon, we believe that diverse and inclusive teams are critical to the success of our people and our business. Everyone is welcome—as an inclusive workplace, we do not discriminate. In fact, we embrace differences and are fully committed to creating equal opportunities, an inclusive environment, and fairness for all. Respect is the cornerstone of how we operate, so speak up and be yourself. You are valued here. Show more Show less

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors. As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment. Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities. The Role Veeva’s Vault Quality suite is a single authoritative source, enabling greater visibility and control. Vault Quality enables organizations to modernize quality management, assuring quality while driving compliance and operational innovation. We are looking for Consultants with Life Sciences experience and a passion for helping customers optimize their quality data and document management operations in the cloud. What You'll Do Participate in projects at life sciences companies designing and deploying Quality systems Support Functional Analysts in workshops and be part of customer discussions of the Vault Quality suite (Vault QMS, Vault QualityDocs, Vault Training) Quality/Content management solution design, prototyping, configuration, and documentation Solution and configuration of Veeva Vault Quality Suite per customer requirements, including workflows, document types, security, fields, page layouts, reports, dashboards, formatted output reports, and notifications Leveraging enablement of out-of-the-box or best practices configuration approach to solution strategy Assessing the impact of change on the current configuration and working with key stakeholders to make informed decisions in a timely manner Represent Professional Services across multiple engagements and workstreams (e.g., solution design and configuration, data migration, systems integration, etc.) Ensure customer success from the beginning to the end of the engagement life cycle Requirements 4+ years of experience implementing Document or Quality Management systems for life sciences as a consultant, business, or IT representative Bachelor's Degree in Life science, computer science, or related degree Solid analytical and great interpersonal skills Excellent communication skills (written and verbal) Strong attention to detail Highly organized Ability to act with speed to understand business requirements and willingness to "roll up your sleeves" to design and implement a solution Exposure to life sciences compliance and computer systems validation requirements Nice to Have Understanding of global quality requirements, compliance considerations, and processes for Quality process and content management, life sciences compliance, and/or computer systems validation Proven track record leading high-impact global system implementation programs as a consultant, business, or IT lead, and/or business sponsor Direct experience with systems, such as Veeva Vault, ETQ Reliance, Sparta TrackWise, OpenText, SharePoint, Documentum D2, FirstDoc FirstPoint, NextDocs, UL ComplianceWire, and other quality information management or content management systems SaaS/Cloud experience Knowledge of Quality operations within the Life Sciences, Pharmaceutical, Biotech industry, and/or equivalent. Perks & Benefits Flexible PTO Health & wellness programs Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. Show more Show less

What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible. Position Summary This position is responsible for Supplier Quality activities that improve, monitor and measure Illumina’s compliance with the Quality System Regulations, Illumina’s Quality policies, FDA regulations and ISO standards as well as Illumina product quality requirements for current operational objectives. Participates in continuous improvement activities of Illumina’s suppliers, purchased parts and purchasing controls. Responsibilities Responsible in qualification, evaluation and monitoring activities of new suppliers and partners for Illumina products and outsourced services Collaborates with cross-functional subject matter experts to coach and represent partner and service supplier processes. Participate as a core/extended Quality team member of new product development and sustaining teams to assure processes are in place to design and release highly reliable and safe products Drives process, quality and product improvements through supplier and partner development activities, risk management, identification and resolution of current and potential issues Responsible for updates to purchasing control procedures and processes as needed to stay compliant to quality system requirements and regulations. Provides Quality Assurance expertise and guidance for Service Supplier, Partner Development, and Product Quality Leads and facilitates Quality Investigations and CAPA/SCARs to resolve Quality issues with Service Supplier and Partner, ensuring mitigations, containment and corrective actions are implemented in a timely manner Leads supplier/partner audits to drive process standardization and continuous improvement, including audit action timely resolution and closure. Support Global team initiatives including supplier/partner performance reviews, corporate and site Quality Management Reviews and more. Supports regional initiatives associated with Service Supplier and Channel Partner process improvements and issue resolution. Make recommendations, and drive programs to improve channel partners and service supplier performance Reviews non-conformance, Quality Investigations, Complaints and CAPA reports to identify actions needed to track and improve program health by site or globally. Works with strategic partners and suppliers to ensure global awareness and compliance to procedures and specifications Ability to provide training to other team members to ensure consistency and compliance to processes and procedures. Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs. Requirements Experience collaborating with cross-functional product development and operational teams (Global HQ teams and local/regional teams) Strong QMS auditing (ISO 13485, ISO 9001, ISO 17025) experience Strong communication, presentation and negotiation skills Working knowledge and experience with Quality Management Systems, Project Management, and Process Engineering methodologies and tools Experience with Non-conformance Handling, Failure Investigation (CAPA/SCAR) and Risk Management (FMEA) activities. Demonstrated capability in successfully managing and leading change Practice identifying, mitigating, and resolving risks Ability to work effectively in a fast-paced, dynamic environment with shifting and competing priorities Demonstrated experience in Supplier Quality and Management activities such as component qualification, audits, risk assessments. Experience with electronic product life cycle (PLM) systems such as EtQ, SAP or other PLM systems. Practical experience in FDA and ISO regulated environments is a plus Experience with statistical analysis Ability to travel domestically and internationally as needed. Estimate 25% of the time. Ability to work PST hours to collaborate with teams in HQ in San Diego All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities. Experience/Education BS or equivalent in a technical discipline with 5+ years of experience. MS in a technical discipline with 3+ years of experience. PHD in a technical discipline with 1-3 years of experience. Experience working in a regulated environment, in-vitro diagnostics preferred. We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship. Show more Show less

The Opportunity The QA Specialist in IND plays a crucial role in overseeing the quality assurance processes across the company’s three manufacturing sites (Mumbai, Panoli, and Dehradun). The core responsibility of this position is managing and resolving non- product quality issues, ensuring adherence to quality control procedures, and maintaining product excellence by collaborating with various teams, the specialist acts as the primary contact for resolving non-conformance issues and minimizing the recurrence of quality problems. QA Specialist is a vital role that ensures high standards of product quality, operational excellence, and regulatory compliance across the company’s manufacturing operations. What We’re Looking For Education: B.Sc/M.Sc (Chemistry, Biology, Microbiology) Experience: Minimum 5-8 years of experience How You Will Thrive And Create An Impact Non-Product Quality Issue Management: Identify, document, and resolve non-product related quality issues across the Mumbai, Panoli, and Dehradun manufacturing sites. Ensure compliance with established quality control procedures, work instructions, and GMP standards. Monitor and address non-conformance issues to prevent recurrence, coordinating with relevant teams and departments. Site Coordination & Communication Serve as a liaison between the three manufacturing sites, ensuring smooth communication and effective resolution of non-product quality issues. Collaborate with site managers, production teams, and quality specialists to ensure consistent quality control practices across all sites. Compliance with Regulatory Requirements: Ensure actions taken to address non-product quality issues comply with internal policies and external regulatory requirements (e.g., GMP, ISO). Perform audits, review documentation (e.g., COA/COC), and ensure adherence to quality standards at all times. Root Cause Analysis and Corrective Actions: Utilize problem-solving tools like 5M+E and 5 Why’s to identify root causes of non-product quality issues. Implement corrective actions across all three sites to ensure issues are effectively addressed and do not recur. Continuous Improvement: Drive continuous improvement initiatives to optimize processes and reduce non-conformance issues. Collaborate with site-specific and regional teams to improve overall product quality and operational efficiency. Documentation and Reporting: Oversee the documentation of non-product quality issues and track trends to ensure timely resolution. Prepare and maintain accurate and timely reports on quality control activities and issues identified across all sites. Customer Complaint Investigations Lead and manage all investigations related to customer complaints, ensuring thorough root cause analysis and timely resolution to improve customer satisfaction. Audit Oversight: Oversee internal and external audits to ensure compliance with ISO 9001:2015, Medical Devices, GDP, and other relevant standards. Serve as the appointed Lead Auditor for relevant certifications, ensuring audits align with regulatory requirements. Quality Management Systems (QMS): Develop, implement, and maintain the QMS to ensure compliance with ISO regulatory standards. Drive the continuous improvement of the QMS by incorporating best practices, process enhancements, and risk mitigation strategies. Document Management: Oversee the document control system to ensure all documentation is up-to-date, compliant, and easily accessible for review during audits. ETQ System Development and Training: Lead the development and training of the ETQ system across the DC IND to ensure teams are proficient in system usage for quality management and compliance. Quality Culture and Continuous Improvement: Foster a culture of continuous improvement at the IND manufacturing site, guiding cross-functional teams to optimize quality performance. Spearhead quality improvement initiatives, encouraging a culture of excellence across all operations. Third-Party Logistics & Warehouse Audits: Oversee audits of third-party logistics providers and extended warehouses, ensuring compliance with quality standards and regulatory requirements. Certification Management: Lead and maintain certification audits to ensure compliance with ISO and industry-specific standards. Ensure the organization consistently meets regulatory demands. Essential Skills and Qualifications: Extensive experience in quality assurance within regulated industries (ISO 9001:2015, Medical Devices, GDP). Strong knowledge of QMS, audit processes, and document control. Proven ability to lead and manage cross-functional teams in driving continuous improvement and compliance. Strong analytical skills, with experience in customer complaint investigations. Certification in ISO lead auditing or similar credentials. Excellent communication, leadership, and training skills. Support Label Replacement Requests: Work closely with the supply chain led to support label replacement requests. Coordinate actions related to containment and corrective actions if needed to address any quality issues. Disclaimer The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer. Why Avantor? Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science. The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor. We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today! EEO Statement We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at recruiting@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. 3rd Party Non-solicitation Policy By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation Show more Show less

Architect and implement enterprise integration solutions using Azure services such as: Azure Functions Azure Logic Apps Azure API Management (APIM) Azure Service Bus / Event Grid Azure Data Factory (for data orchestration) Design and develop Applications with custom HTTP connectors to integrate with external APIs (e.g., .NET, ETQ). Integrate with SAP and ETQ systems using custom APIs for modules like Suppliers, Materials, CAPA, SCAR, Deviation, and Non-Confirmation. Manage Azure Active Directory (AAD) for secure authentication and role-based access. Handle large-scale data processing using Azure Blob Storage , Asynchronous Web Jobs , and Azure SQL Database . Build and maintain custom connectors in Power Platform for reusable integrations. Implement pagination and optimized grid views in PowerApps for handling >2000 records efficiently. Enable notifications and alerts through Azure Functions and third-party messaging/email services. Establish and maintain CI/CD pipelines using Azure DevOps for automated deployment. Apply Infrastructure as Code (IaC) practices using ARM templates or Bicep . Implement robust logging, monitoring, and error handling for all integration components. Collaborate with architects, analysts, and developers to understand business requirements and deliver technical solutions. Provide technical leadership and mentorship to junior developers and promote best practices. Required Skills & Experience: 3+ years of experience in Azure development and integration solutions . Deep expertise in Azure Integration Services (Functions, Logic Apps, APIM, Service Bus). Strong understanding of RESTful APIs , HTTP , JSON , and API security . Experience with Azure SQL Database , Blob Storage , and asynchronous data processing. Background in integrating with SAP , ETQ , and .NET-based enterprise systems . Familiarity with AAD , RBAC , and enterprise-grade authentication mechanisms. Hands-on experience in CI/CD , IaC , and automated deployment pipelines. Strong problem-solving, debugging, and performance tuning skills. Show more Show less