415 Gxp Jobs - Page 5

What you will do We are looking for a seasoned IAM Architect with deep expertise in designing and implementing enterprise-grade identity and access management solutions. The ideal candidate will have hands-on experience with SailPoint Identity Security Cloud (ISC), Ping Identity, Microsoft Entra ID, Okta, and Privileged Access Management (PAM) platforms. This role requires a strategic thinker with strong technical skills to lead IAM architecture initiatives across hybrid and multi-cloud environments. Roles & Responsibilities: Design and Develop the Amgens enterprise Identity and Access architecture vision and strategy, ensuring alignment with business objectives Architect, implement and mana...

What you will do In this you will be the senior individual contributor within Amgens Enterprise Resource Planning (ERP) Testing team. this role requires a highly skilled testing professional who can take end-to-end ownership of SAP ERP testing activities and design/implement automation solutions from scratch using industry-leading tools Roles & Responsibilities: Testing Ownership Perform the planning, preparation, and execution of test cases for SAP ERP programs, ensuring alignment with project and compliance requirements. Perform hands-on testing (both manual and automated) while driving quality outcomes for ERP releases. Test Automation Leadership Design, build, and implement automation fr...

Senior Manager, Manufacturing Systems Data Data Historian, Batch Reporting & Analytics What you will do This strategic global leadership role will be accountable for architecting, building, and evolving the Manufacturing Systems Data COE, overseeing deployment, lifecycle management, and governance of manufacturing data platforms, batch reporting solutions, and analytics across Amgens global manufacturing network. As the Senior Manager, you will direct a high-performing team of data engineers, analysts, and solution architects, ensuring effective delivery and continuous advancement of Data Historian infrastructures, batch reporting solutions, and analytics platforms. You will partner closely ...

Responsible for management of IT infrastructure,network security & CSV in compliance with cGMP & 21CFR Part11 guidelines. Ensures continuous operation of servers,networks & GMP systems while maintaining data integrity,security & regulatory compliance

Amgen is seeking a Supplier Onboarding & Vendor Master Senior Associate who will be part of Amgens Global Procure to Pay (P2P) organization. You will be responsible for supporting global supplier enablement activities including supplier on-boarding, vendor master data management, set up and enablement of electronic transacting over shared systems, and catalog management. The Supplier Onboarding Senior Associate role will report to the Supplier Onboarding & Vendor Master Manager. The role will be based in India. Primary responsibilities will include the following: Supplier Onboarding & Vendor Master Management Support business partners on the Supplier On-boarding process, helping resolve issu...

What you will do In this vital role you will as an Associate System Analyst Veeva Test Engineer at Amgen, you will join the Amgens Veeva Validation Team to help develop test strategies for various Veeva releases in Amgen. You will also assist the operations team in investigating issues with validated Veeva features. Roles & Responsibilities: Develop comprehensive test plans and strategies based on project specifications and requirements. Perform manual and automated testing of software applications, including functional, regression, and performance testing. Document and report defects identified during testing and collaborate with development teams for resolution. Maintain detailed records o...

What you will do We are seeking an individual who thrives in ambiguity, capable of driving digital procurement initiatives with precision and purpose. You will support the implementation of strategies, systems, and processes that enable efficient and effective procurement solutions aligned with our ambitious goals. Reporting to the Source-to-Contract (S2C) Technology Enablement Lead, your responsibilities will include supporting the implementation of the Digital Procurement strategy, documenting and translating requirements, driving design changes and system integrations, conducting maintenance and upgrades, and enabling user experience capabilities through innovative tools and applications....

What you will do In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation. This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for quali...

What you will do This role is central to the modernization and digital transformation of our industrial systems, ensuring operational excellence, compliance, and agility for future growth. As a member of our Digital, Technology & Innovation organization, you will collaborate with global teams of engineers, automation specialists, IT professionals, and operations leadership to deliver robust, scalable, and compliant IoT solutions. Your leadership will help drive the transformation of our industrial network, leveraging state-of-the-art technologies and integrating IoT with enterprise systems. Roles & Responsibilities Lead end-to-end design, development, and implementation of our industrial IoT...

What you will do In this vital role, you will support the qualification, validation, and compliance processes for SAP ERP solutions and related platforms. You will work closely with senior team members, Quality, and business partners to ensure validation deliverables are executed to meet industry standards and regulatory requirements in a Life Sciences environment. Roles & Responsibilities: Execute validation deliverables for SAP ERP systems (ECC, S/4HANA, BTP, GRC, and related platforms) in alignment with Amgens procedures and regulatory expectations. Support the creation, execution, and review of validation documentation (e.g., Validation Plan, Requirements, IQ, OQ, PQ/UAT test scripts, Tr...

What you will do As an Associate System Analyst Veeva Test Engineer at Amgen, you will join the Amgens Veeva Validation Team to help develop test strategies for various Veeva releases in Amgen. You will also assist the operations team in investigating issues with validated Veeva features. Roles & Responsibilities: Develop comprehensive test plans and strategies based on project specifications and requirements. Perform manual and automated testing of software applications, including functional, regression, and performance testing. Document and report defects identified during testing and collaborate with development teams for resolution. Maintain detailed records of test plans, test cases, an...

What you will do We are seeking an individual who thrives in ambiguity, capable of driving digital procurement initiatives with precision and purpose. You will support the implementation of strategies, systems, and processes that enable efficient and effective procurement solutions aligned with our ambitious goals. Reporting to the Source-to-Contract (S2C) Technology Enablement Lead, your responsibilities will include supporting the implementation of the Digital Procurement strategy, documenting and translating requirements, driving design changes and system integrations, conducting maintenance and upgrades, and enabling user experience capabilities through innovative tools and applications....

Role & responsibilities Support on IT quality systems framework design and implementation Managing the reviews and assessments for IT quality Assist in Computer System Validation (CSV) compliance of GxP processes for pharmaceutical companies or experience on quality compliance services for global consumer health care, medical devices, and pharmaceutical companies GxP Business process review Development of integrated GxP and IT compliance Standard operating procedures and guidelines GxP and IT compliance assessment Define the Validation strategy of IT Software and Systems Actively participate in the Validation Life Cycle of regulated IT projects or platforms by planning validation deliverable...

What you will do In this vital role you will as an Associate System Analyst Veeva Test Engineer at Amgen, you will join the Amgens Veeva Validation Team to help develop test strategies for various Veeva releases in Amgen. You will also assist the operations team in investigating issues with validated Veeva features. Roles & Responsibilities: Develop comprehensive test plans and strategies based on project specifications and requirements. Perform manual and automated testing of software applications, including functional, regression, and performance testing. Document and report defects identified during testing and collaborate with development teams for resolution. Maintain detailed records o...

What you will do This strategic leadership role is accountable for building, managing, and evolving the global MES COE, overseeing MES and adjacent systems deployments, lifecycle management, and governance for all manufacturing sites across Amgens network. As the Sr Manager, you will direct a high-performing team of MES engineers, and technical specialists, ensuring the effective delivery and continuous improvement of MES solutions. You will partner with cross-functional leaders in Digital, Technology & Innovation, Operations, Quality, IT, and Automation to drive Amgens NextGen MES strategyfrom vision through executionsupporting seamless integration with SAP, automation, cloud, and data plat...

What you will do We are seeking an individual who thrives in ambiguity, capable of driving data and analytics initiatives with precision and purpose. You will support the implementation of strategies, systems, and processes that enable data-driven decision-making across procurement and supply chain. Reporting to the Source-to-Contract (S2C) Technology Enablement Lead, your responsibilities will include designing the analytics strategy, building pipelines, integrating platforms, enabling visualization capabilities, leveraging GenAI tools, and delivering actionable insights that inform strategic sourcing and procurement decisions. Roles & Responsibilities Data & Analytics Strategy Develop and ...

The Sr. Associate IS Engineer position offers a unique opportunity to join a fun, innovative engineering team within the AI & Data Science (AI&D) - Enterprise Automation organization. Youll work on next-generation capabilities and services in Applied AI & Automation using innovative COTS products, open-source software, frameworks, tools, and cloud computing services. The role also emphasizes demonstrating these capabilities to support critical business operations and initiatives, in ensuring quality, compliance, and performance across Amgens Applied AI & Automation Footprint. As Sr. Associate IS Engineer, you will become an integral part of the Self-Service Automation(SSA) and Custom GPT Pra...

Hi, We are having an opening for Manager IT- Trackwise at our Baroda location Job Summary : To lead the end-to-end implementation of the Quality applications (Preferably Trackwise) across the organization, ensuring alignment with regulatory requirements (GxP, 21 CFR Part 11), business needs, and global quality standards. Responsible for configurations and implementation and support quality systems to ensure Computer Systems, projects, processes and services meet their business and regulatory requirements. Follow the procedures defined in the Global SOPs during activities required for configuration and implementation of IT systems. Areas Of Responsibility : Oversee configuration, customizatio...

What you will do We are seeking an individual who thrives in ambiguity, capable of driving digital procurement initiatives with precision and purpose. You will support the implementation of strategies, systems, and processes that enable efficient and effective procurement solutions aligned with our ambitious goals. Reporting to the Source-to-Contract (S2C) Technology Enablement Lead, your responsibilities will include supporting the implementation of the Digital Procurement strategy, documenting and translating requirements, driving design changes and system integrations, conducting maintenance and upgrades, and enabling user experience capabilities through innovative tools and applications....

ABOUT THE ROLE Role Description: We are seeking a Senior Data Engineering Manager with a strong background in Regulatory or Integrated Product Teams within the Biotech or Pharmaceutical domain. This role will lead the end-to-end data strategy and execution for regulatory product submissions, lifecycle management, and compliance reporting, ensuring timely and accurate delivery of regulatory data assets across global markets. You will be embedded in a cross-functional Regulatory Integrated Product Team (IPT) and serve as the data and technology lead, driving integration between scientific, regulatory, and engineering functions to support submission-ready data and regulatory intelligence soluti...

What you will do In this vital role you will demonstrate domain and business process expertise to create test plans & test scripts for software development teams and implement testing activities. This role involves working closely with Product Owner, Business analysts, and Developers to ensure that technical requirements for upcoming development are thoroughly elaborated and tested. This enables delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure quality and performance of IT Systems. This role will collaborate with Product Owner and developers to maintain an efficient and consistent testing process, ensuring quality de...

Principal Manufacturing Systems Engineer - Advanced Application Development What you will do This role is central to the modernization and digital transformation of our manufacturing environment, focusing on cutting-edge technologies such as machine vision solutions, IoT applications, and Smart Manufacturing Solutions. Roles & Responsibilities Lead the end-to-end development, configuration, and implementation of advanced manufacturing systems and automation technologies. Drive system modernization and digital transformation by integrating machine vision solutions, IoT applications, and Smart Manufacturing Solutions. Serve as the technical authority and subject matter expert for PLC/SCADA sys...

What you will do Lets do this. Lets change the world. The Associate IS Business System Analyst position offers a unique opportunity to join a fun, innovative engineering team within the AI & Data Science (AI&D) - organization. Youll work on next-generation capabilities and services in Applied AI & Automation using innovative COTS products, open-source software, frameworks, tools, and cloud computing services. The role also emphasizes demonstrating these capabilities to support critical business operations and initiatives, in ensuring quality, compliance, and performance across Amgens Applied AI & Automation Footprint. The role leverages domain and business process expertise to detail product...

Role Description: The Sr Associate IS Business System Analyst position offers a unique opportunity to join a fun, innovative engineering team within the AI & Data Science (AI&D) - organization. Youll work on next-generation capabilities and services in Applied AI & Automation using innovative COTS products, open-source software, frameworks, tools, and cloud computing services. The role also emphasizes demonstrating these capabilities to support critical business operations and initiatives, in ensuring quality, compliance, and performance across Amgens Applied AI & Automation Footprint. The role leverages domain and business process expertise to detail product requirements as epics and user s...

Role Description: The role is responsible for leading the team to support and maintain the Amgen Veeva Vault Platform. The role will be involved in defining Amgens Veeva Vault Platform support strategy, guiding technology decisions, and ensuring timely service is provide to the Amgen Veeva Vault platform users and their issues are resolved. The ideal candidate will have a proven track record of leadership in technology-driven environments, managing technology platforms, digital transformation initiatives, and have a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with cross-functional and global teams is required to ensure seamless i...