20 Gxp Validation Jobs

Ready to build the future with AI? At Genpact, we dont just keep up with technology—we set the pace. AI and digital innovation are redefining industries, and we’re leading the charge. Genpact’s AI Gigafactory, our industry-first accelerator, is an example of how we’re scaling advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. From large-scale models to agentic AI, our breakthrough solutions tackle companies’ most complex challenges. If you thrive in a fast-moving, innovation-driven environment, love building and deploying cutting-edge AI solutions, and want to push the boundaries of what’s possible, this is your moment. Genpact (NYSE: ...

You are an experienced professional with 15-20 years of expertise in digital transformation of Supply Chain processes. You will be responsible for implementing and maintaining Kinaxiss IBP Enterprise Level solution into Pharmaceutical / BioPharma / BioTech Organization, covering all the Phases of S&OP Processes. Your skills and knowledge in SAP S/4HANA, Oracle, Blue Yonder, Kinaxis, or ERP/WMS/APS systems, along with a strong understanding of GxP validation, supply chain planning, manufacturing logistics, serialization, and cold chain operations will be crucial. Additionally, proficiency in Agile/Waterfall project methodologies, ITIL practices, and cybersecurity principles, as well as except...

As an experienced professional with 13-20 years of experience in digital transformation of Supply Chain processes, we are seeking a candidate with a minimum of 5 years of strong experience in implementing and maintaining Kinaxiss IBP Enterprise Level solution within Pharmaceutical / BioPharma / BioTech organizations covering all phases of S&OP processes. Your expertise in SAP S/4HANA, Oracle, Blue Yonder, Kinaxis, or ERP/WMS/APS systems will be essential for this role. In this role, you will be responsible for strategic planning, roadmap development, enterprise systems leadership, GxP compliance, validation oversight, cross-functional collaboration, project and program management, and operat...

Ready to build the future with AI At Genpact, we don't just keep up with technology-we set the pace. AI and digital innovation are redefining industries, and we're leading the charge. Genpact's AI Gigafactory, our industry-first accelerator, is an example of how we're scaling advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. From large-scale models to agentic AI, our breakthrough solutions tackle companies most complex challenges. If you thrive in a fast-moving, innovation-driven environment, love building and deploying cutting-edge AI solutions, and want to push the boundaries of what's possible, this is your moment. Genpact (NYSE: G...

Ready to build the future with AI At Genpact, we don't just keep up with technology-we set the pace. AI and digital innovation are redefining industries, and we're leading the charge. Genpact's AI Gigafactory, our industry-first accelerator, is an example of how we're scaling advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. From large-scale models to agentic AI, our breakthrough solutions tackle companies most complex challenges. If you thrive in a fast-moving, innovation-driven environment, love building and deploying cutting-edge AI solutions, and want to push the boundaries of what's possible, this is your moment. Genpact (NYSE: G...

**Job Description:** **Role Overview:** As the Director of Supply Chain IT at Thermo Fisher Scientific, you will lead the strategic direction, governance, and execution of technology initiatives supporting end-to-end supply chain operations within a global pharmaceutical CDMO. Your role will involve ensuring robust, compliant, and data-driven systems enable efficient planning, sourcing, manufacturing, warehousing, and distribution processes across GxP environments. You will partner with multi-functional collaborators to drive digital transformation and digital strategy, lead complex multi-site SAP S/4HANA and SCM system integrations, and ensure continuity and visibility across internal and e...

As a skilled and detail-oriented GxP Validation Tester with over 3 years of experience in software testing within regulated environments, you will be responsible for conducting GxP validation and compliance testing of applications to ensure adherence to FDA/EMA guidelines. Your expertise in database testing using SQL, Unix commands, and knowledge of Azure cloud environments will be crucial in ensuring the quality and accuracy of data systems. Collaboration with development and DevOps teams is essential to ensure end-to-end system functionality. Key Responsibilities: - Execute test cases on Unix-based environments - Prepare and maintain validation documentation - Support cloud-based testing a...

Ready to build the future with AI At Genpact, we don&rsquot just keep up with technology&mdashwe set the pace. AI and digital innovation are redefining industries, and we&rsquore leading the charge. Genpact&rsquos AI Gigafactory, our industry-first accelerator, is an example of how we&rsquore scaling advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. From large-scale models to agentic AI, our breakthrough solutions tackle companies most complex challenges. If you thrive in a fast-moving, innovation-driven environment, love building and deploying cutting-edge AI solutions, and want to push the boundaries of what&rsquos possible, this is...

Roles & Responsibilities: Oversee the software, hardware, and firmware development lifecycle for CDS application, ensuring standard methodologies in development, testing, and deployment across the Global Process Development Organization Work within the framework of SAFe product team, participating in requirements gathering, design discussions, development, implementation, testing, and software validation. Ensure the quality, reliability, and scalability of the CDS applications, following the standard methodologies of software engineering, testing, and documentation. Research and evaluate new technologies and frameworks that can enhance the capabilities and performance of the software solutio...

Roles & Responsibilities: Plan, coordinate, and lead the execution of validation activities, including qualification and validation of data products and software applications. Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen s SOPs and ensure validation practices are aligned with evolving standards. Contribute to test automation scripting, framework mainte...

As a skilled and detail-oriented GxP Validation Tester with over 3 years of experience in software testing within regulated environments, you will be responsible for conducting GxP validation and compliance testing of applications to ensure adherence to FDA/EMA guidelines. Your expertise in database testing using SQL, Unix commands, and knowledge of Azure cloud environments will be crucial in ensuring the quality and accuracy of data systems. Collaboration with development and DevOps teams is essential to ensure end-to-end system functionality. Your key responsibilities will include executing test cases on Unix-based environments, preparing and maintaining validation documentation, supportin...

As a skilled and detail-oriented GxP Validation Tester with over 3 years of experience in software testing within regulated environments, you will play a crucial role in ensuring the quality and accuracy of software solutions. Your expertise in GxP validation, database testing, Unix commands, SQL, and knowledge of Azure cloud environments will be essential for this role. Your key responsibilities will include conducting GxP validation and compliance testing of applications to ensure adherence to FDA/EMA guidelines, performing database testing using SQL to validate backend data integrity and business logic, executing test cases on Unix-based environments, collaborating with development and De...

Key Deliverables: Define and execute validation strategies for GxP-regulated IT systems Create and manage validation documentation using Veeva VM Testing Vault Execute test cases, track defects, and ensure compliance with regulatory standards Generate reports and dashboards on validation progress and defect metrics Role Responsibilities: Collaborate with system architects, QA, and business teams to align validation plans Maintain audit-ready documentation and manage workflows in validation tools Support end-users and conduct training on validation systems and best practices Ensure adherence to FDA 21 CFR Part 11, GxP, and global regulatory frameworks

Key Deliverables: Lead agile delivery across Veeva Vault systems using SAFe methodology Facilitate product backlog grooming and define user stories with clear acceptance criteria Align product roadmap with stakeholder needs and regulatory compliance Support validation strategy, documentation, and risk assessment Role Responsibilities: Coach agile teams and manage Scrum/SAFe ceremonies Ensure compliance with 21 CFR Part 11 and GxP best practices Drive continuous improvement through collaboration and feedback loops Coordinate globally with cross-functional stakeholders for effective delivery

Key Deliverables: Manage Veeva Vault eTMF operations, configurations, and enhancements Develop custom reports, SDK modules, and integration components Ensure GxP-compliant software through validation and documentation Collaborate on system upgrades, releases, and platform governance Role Responsibilities: Analyze business needs and translate them into technical solutions Design and implement automated tests and deployment processes Maintain system uptime and performance while addressing incidents Integrate eTMF with external tools for seamless data flow

Key Deliverables: Maintain and enhance Veeva Vault RIM applications and custom modules Ensure validated, GxP-compliant software through testing and documentation Integrate Vault RIM with other systems and manage seamless data flow Deliver high-quality releases by collaborating with cross-functional teams Role Responsibilities: Translate business needs into software designs and configurations Perform code development, version control, and automated testing Stay current with Veeva platform updates and governance best practices Support incident management, operations, and platform performance

Key Deliverables: Lead operations and maintenance of Vault PromoMats and MedComm systems Design and develop custom Veeva Vault configurations and integrations Ensure GxP compliance through validation and risk-based testing Create reports, SDK enhancements, and integration solutions Role Responsibilities: Collaborate with cross-functional teams to deliver software solutions Stay updated with Veeva platform features and governance best practices Write clean, validated, and well-documented code for regulated environments Manage system performance, version control, and incident response

What you will do In this vital role you will be working closely with Business collaborators, Product Owner, Business Analysts, Developers, and Testers to ensure that Validation strategy and work are produced for IT Systems. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes. The successful candidate will work on a small team and support continuous improvements and automation within the program. This position combines technical expertise, validation experience, and a strong understanding of regulatory requirements. The role also demonstrates domain and business process expertise to drive ongoing improvements to validatio...

What you will do In this vital role you will be part of the Chromatography Data Systems (CDS) Product Team and will be responsible for driving Life Cycle Management of Empower, Chromeleon, Unicorn and other CDS applications, including GxP validation, testing, and compliance activities, remediation of software vulnerabilities, and managing backup and disaster recovery plans for CDS applications. You will work closely with Lab Scientists, Benchtop Technicians, Product owners, and Business analysts following SAFe Agile methodologies to drive Platform and Product Innovation beyond the KTLO activities to help accelerate Operational Business Goals and advance Amgens mission of serving every patien...

Let's do this. Let's change the world. We are seeking an experienced Validation Engineer to work on a GxP platform supporting the Regulatory Submission system and Clinical Trial Registry system. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes. The successful candidate will work on a small team and support continuous improvements and automation within the program. This position combines technical expertise, validation experience, and a strong understanding of regulatory requirements. The role also leverages domain and business process expertise to drive ongoing improvements to validation and meets our regulatory and v...