8 Gxp Validation Jobs

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 validation and meets our regulatory and validation procedures. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and validated. Roles & Responsibilities: Collaborate with System Architects and Product owners to manage Validation strategy and Deliverable for the GxP applications. Develop and manage test cases, protocols, and validation documentation within the Veeva VM Testing Vault. Implement test scripts to ensure system compliance with regulatory requirements and organizational standards. Identify, document, and track defects during the testing process. Collaborate with development teams to resolve defects and validate fixes. Ensure all testing and validation activities align with GxP, FDA 21 CFR Part 11, and other regulatory standards. Maintain comprehensive audit trails and validation documentation to support regulatory inspections. Configure and optimize workflows within the VM Testing Vault to streamline test management and approval processes. Partner with quality assurance, IT, and business teams to ensure alignment on validation objectives and testing requirements. Act as a liaison between technical teams and customers to ensure system requirements are met. Provide training to end-users on Veeva VM Testing Vault functionalities and standard processes. Offer ongoing support to ensure effective use of the platform. Generate reports and dashboards to monitor testing progress, defect trends, and validation status. Basic Qualifications and Experience: Masters degree with 4 - 6 years of experience in Computer Science, Business, Engineering, IT or related field OR Bachelors degree with 6 - 8 years of experience in Computer Science, Business, Engineering, IT or related field OR Diploma with 10 - 12 years of experience in Computer Science, Business, Engineering, IT or related field. Functional Skills: Must-Have Skills: Solid understanding of GxP regulations, specifically 21 CFR Part 11. Expertise in defining and implementing validation strategies aligned with regulatory requirements. Experience in creating and driving validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)). Excellent communication skills and the ability to collaborate with senior leadership with confidence and clarity. Familiarity with GxP Validation management tools such as ALM, Veeva Vault Management etc. Good-to-Have Skills: Proficiency in automation tools and validation software (Application Lifecycle Management and/or Veeva Vault Validation Management). Experience of DevOps, Continuous Integration and Continuous Delivery methodology. Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies. Professional Certifications: SAFe for Teams certification (preferred) Veeva VM certification (preferred) Soft Skills: Able to work under minimal supervision. Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work. Excellent analytical and gap/fit assessment skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills. Shift Information: This position operates on the second shift, from 2:00 PM to 10:00 PM IST. Candidates must be willing and able to work during these hours.

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 patient every time 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 solutions. Remain accountable for ensuring overall organizational compliance with quality and GxP in technology services Monitor emerging technologies and trends to find opportunities for platform growth and expansion Apply machine learning and Gen AI techniques to accelerate operational business process flows associated with CDS applications and leverage CDS data to generate insights and provide recommendations for process improvement. Doctorate degree OR Masters degree and 4 to 6 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelors degree and 6 to 8 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 10 to 12 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Preferred Qualifications: Functional Skills: Must-Have Skills: Demonstrated experience of owning business applications in a Life Sciences, Pharmaceutical, Biotech company or equivalent industry or knowledge of the pharmaceutical industry GxP system qualification and validation processes for computer related systems Strong knowledge of COTS (Commercial-off-the-shelf) Validations on HPLCs, UPLCs, CEs, GCs, and other standalone systems Proven leadership skills with the ability to lead projects and work closely with a team of hard-working technology professionals Build a culture of innovation and continuous improvement within the team to deliver powerful solutions and platform improvements Solid skills in collaborating and communicating with multi-functional teams, business collaborators, and executives to ensure alignment of platform initiatives with business outcomes, handling expectations, and ensuring successful delivery of projects. Experience with Advancing Capabilities and Delivering Innovative Technology Solutions in a Pharma/Biotech environment Degree in Computer Science, Information Systems, Engineering, or Life Sciences Good-to-Have Skills: At least 5 8 years of domain knowledge in health and/or life sciences combined with Information Technology Extensive experience in software development lifecycles Experience using and adoption of Scaled Agile Framework (SAFe) Understanding of ITIL processes and implementation Experience handling vendor relationships and working with external partners or consultants to ensure optimal performance, support, and development of digital products Soft Skills: Excellent leadership and team management skills. Strong transformation and change management experience. Ability to work effectively with global, virtual teams. Excellent analytical and troubleshooting skills. Ability to manage multiple priorities successfully. Strong presentation and public speaking skills. Strong verbal and written communication skills. High degree of initiative and self-motivation.

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 validation procedures. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and validated. 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, and test results to ensure traceability and compliance. Validate test scenarios against feature acceptance criteria and customer expectations. Ensure system compliance with regulatory requirements for data integrity, traceability, and reliability. Identify opportunities to enhance testing efficiency and minimize manual efforts. Evaluate and adopt tools and technologies to improve automation capabilities. Keep validation documentation updated and aligned with GxP standards. Ensure strict adherence to change management processes for validated systems. Stay informed on industry trends, emerging technologies, and regulatory updates relevant to GxP. Provide expert technical support in validation to optimize quality, efficiency, and cost for developing, troubleshooting, and improving new and existing applications and platforms. What we expect of you: We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master's degree and 1 to 3 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor's degree and 3 to 5 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Experienced in GxP validation process Have 4-5 years of experience in the Pharmaceutical Industry Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology Experience with Agile software development methodologies (Scrum) Excellent communication skills and the ability to interface with senior leadership with confidence and clarity Experience in writing requirements for the development of a modern web application Strong understanding of GAMP 5 guidelines, 21 CFR Part 11, and Annex 11 Proficiency in automation tools, data systems, and validation software Preferred Qualifications: Experience in Clinical Trial Registry and Regulatory submission publishing systems and processes Knowledge of the Disclose application from Citeline and docuBridge from Lorenz Demonstrated expertise in a scientific domain area and related technology needs Understanding of scientific software systems strategy, governance, and infrastructure Familiarity with low-code, no-code test automation software Technical thought leadership Able to communicate technical or complex subject matters in business terms Knowledge of DevOps, Continuous Integration, and Continuous Delivery methodology Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills