[Hiring] Computer Systems Validation Lead @Capgemini

Role Description

Lead and support Computer Systems Validation (CSV) activities for GxP-regulated computerized systems throughout the System Development Life Cycle (SDLC.

• Ensure compliance with GxP, FDA 21 CFR Part 11, company SOPs, and Quality Management System (QMS) requirements.
• Review, assess, and approve validation deliverables, risk assessments, testing documentation, and change controls.
• Collaborate with Business, Quality Assurance, IT, and external vendors to ensure validated and compliant system implementations.

Qualifications

• Lead and support Computer System Validation (CSV) activities, including preparation and review of Validation Plans, protocols, reports, and compliance documentation across the system lifecycle.
• Conduct GxP compliance and risk assessments, define risk-based validation strategies, and ensure adherence to regulatory requirements such as FDA 21 CFR Part 11 and organizational quality standards.
• Review and oversee testing and qualification activities, including UAT/SIT protocols, test executions, defect management, qualification documentation, and validation evidence to ensure systems are fit for intended use.
• Manage validation documentation and traceability, including requirements reviews, Traceability Matrices, audit-ready records, and data migration/conversion validation activities.
• Support change control, stakeholder collaboration, and continuous improvement initiatives by assessing GxP impact, providing CSV subject matter expertise, and partnering with Quality, Business, IT, and vendors to ensure compliant system implementations.

Benefits

• Flexible work arrangements to maintain a healthy work-life balance.
• Career growth programs and diverse professions to explore a world of opportunities.
• Valuable certifications in the latest technologies such as Generative AI.

Company Description

Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society.

• A responsible and diverse group of 340,000 team members in more than 50 countries.
• Strong over 55-year heritage, trusted by clients to unlock the value of technology to address the entire breadth of their business needs.
• Delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering.
• Market leading capabilities in AI, generative AI, cloud and data, combined with deep industry expertise and partner ecosystem.