As part of the reinforcement of the IT & Validation teams of one of our partners, we are looking for a CSV Engineer able to lead the end-to-end validation activities of a large system in a regulated GxP environment.

The position is part of a complex industrial and pharmaceutical context involving manufacturing systems, infrastructure, automation, data integrity, and compliance requirements.

Mission Objectives

• Lead the end-to-end Computer System Validation activities of a complex system
• Drive validation strategy and execution
• Write and review CSV documentation including Validation Plans, Risk Assessments, Traceability Matrixes, IQ/OQ/PQ protocols and summary reports
• Ensure compliance with GxP, CSV and Data Integrity requirements throughout the project lifecycle
• Provide guidance and recommendations regarding validation approaches, compliance risks and remediation actions
• Coordinate validation activiti...