Capgemini Invent is seeking inventive transformation consultants to join our team. We blend strategic, creative, and scientific capabilities to deliver cutting-edge solutions, driving transformation tailored to client challenges. Our approach is informed by science and data, supercharged by creativity and design, and underpinned by technology created with purpose.

This role focuses on leading and supporting Computer Systems Validation (CSV) for GxP-regulated systems throughout their lifecycle. You will ensure compliance with GxP, FDA 21 CFR Part 11, company SOPs, and QMS requirements. Collaboration with Business, QA, IT, and vendors is key to successful, compliant system implementations.

Lead and support Computer Systems Validation (CSV) activities, including the preparation and review of validation plans, protocols, reports, and compliance documentation across the system lifecycle.

Conduct GxP compliance and risk assessments, establishing risk-based validation strategies aligned with regulatory standards like FDA 21 CFR Part 11 and organizational quality guidelines.

Oversee testing and qualification activities, including UAT/SIT protocols, test execution, defect management, and qualification documentation to verify systems are fit for purpose.

Manage all validation documentation and traceability, ensuring audit-ready records, requirement reviews, and Traceability Matrices are maintained. This includes validation of data migration and conversion activities.

Support change control processes, stakeholder engagement, and continuous improvement by assessing GxP impact, providing CSV expertise, and collaborating with Quality, Business, IT, and vendors for compliant system deployments.

Proven experience in leading and supporting Computer System Validation (CSV) activities is essential.

A strong understanding of GxP compliance and risk assessment methodologies, including the development of risk-based validation strategies, is required.

Proficiency in regulatory requirements such as FDA 21 CFR Part 11 and organizational quality standards is a must.

Experience in reviewing and overseeing testing and qualification activities, including UAT/SIT, defect management, and validation evidence, is necessary.

Ability to manage validation documentation, traceability, and support change control processes is crucial.

Excellent collaboration skills are needed to partner effectively with Business, Quality Assurance, IT, and external vendors.