CSV Engineer
Akkodis · BE
General information Publication date 26/03/2026 Position description Category OPERATIONS - CONSULTING Job title CSV Engineer - Life Sciences - M/F/X Contract...
Job description
General information Publication date: 26/03/2026 Position description: Category: OPERATIONS - CONSULTING: Job title: CSV Engineer - Life Sciences - M/F/X Contract: Permanent contract: Job description: About the role: This role involves ensuring compliance with cGMP standards through the validation of computerized systems. You will be responsible for developing and executing validation studies, generating documentation, and maintaining the validated status of systems. This position requires hands-on involvement and technical expertise in validation processes. Ideally, you have experience in the pharmaceutical sector and a strong understanding of quality and compliance regulations Key responsibilities: - Develop, implement, and execute validation studies for cGMP-critical computerized systems, regarding URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities - Generate validation documentation and assist with protocol execution for computerized systems - Ensure validated status of systems complies with cGMP standards at all times - Manage projects in accordance with Sanofi and cGMP regulatory standards - Provide technical assistance on US FDA and EU validation requirements Business Industry:...