CSV

Capgemini Invent is a place where innovation meets transformation. As forward-thinking consultants, we combine strategic insight, creativity, and scientific rigor to collaborate closely with clients and deliver innovative solutions. Our work is driven by data and science, enhanced by creativity and design, and supported by purposeful technology. Join us to lead change that addresses today’s challenges and anticipates tomorrow’s opportunities.

Key Responsibilities

Lead and support Computer Systems Validation (CSV) activities for GxP-regulated computerized systems throughout the entire System Development Life Cycle (SDLC). Ensure all processes comply with GxP regulations, FDA 21 CFR Part 11, company Standard Operating Procedures (SOPs), and Quality Management System (QMS) requirements. Review, assess, and approve validation deliverables including risk assessments, testing documentation, and change controls. Collaborate effectively with Business units, Quality Assurance, IT teams, and external vendors to guarantee validated and compliant system implementations. Manage validation documentation and traceability, including requirements reviews, Traceability Matrices, audit-ready records, and data migration/conversion validation activities. Support change control processes and continuous improvement initiatives by evaluating GxP impact and providing subject matter expertise in CSV. Oversee testing and qualification activities such as User Acceptance Testing (UAT), System Integration Testing (SIT), defect management, and validation evidence to ensure systems meet intended use criteria.

Required Qualifications

Proven experience leading and supporting Computer System Validation activities, including the preparation and review of Validation Plans, protocols, reports, and compliance documentation across the system lifecycle. Strong knowledge of GxP compliance and risk assessment methodologies, with the ability to define risk-based validation strategies aligned with regulatory requirements such as FDA 21 CFR Part 11 and internal quality standards. Demonstrated expertise in reviewing and managing testing and qualification processes, ensuring comprehensive documentation and validation evidence are maintained. Skilled in managing validation documentation and traceability to maintain audit readiness. Ability to collaborate across multiple stakeholders including Quality, Business, IT, and vendors to ensure compliant system implementations and support change control activities.

Preferred Qualifications and Benefits

Capgemini Invent values flexible work arrangements to support a healthy work-life balance, offering options such as remote work and flexible hours. Career growth is central to our mission, with numerous programs designed to help you explore diverse professional opportunities. Employees have access to certifications in cutting-edge technologies, including Generative AI, to enhance their skills and stay ahead in the industry.

Capgemini is a global leader in business and technology transformation, helping organizations accelerate their journey toward a digital and sustainable future. With over 340,000 team members across more than 50 countries and a heritage spanning more than 55 years, Capgemini is trusted by clients worldwide to unlock the full potential of technology. Our comprehensive services span strategy, design, and engineering, powered by expertise in AI, generative AI, cloud, and data, supported by deep industry knowledge and a strong partner ecosystem.