CSV Engineer

About the role

The CSV Engineer will support the eQMS project from a Computer System Validation (CSV) perspective, ensuring compliance with regulatory standards such as CFR 21 Part 11 and GAMP5. The role involves guiding the project team on data integrity and validation matters.

Key responsibilities

• Coordinate validation activities for the eQMS project and act as the primary contact for CSV and Data Integration questions.
• Define CSV/DI strategy, produce validation documentation (validation plan, FS, DS, FRA, URS, CS, IQ, OQ, PQ test scripts, protocols, AfiU, VSR) and ensure compliance with GMP and internal SOPs.
• Review change requests, CAPAs, and deviations related to CSV and DI, and contribute to CSV&DI guidance.

Required profile

• At least 5 years of experience in CSV documentation and multidisciplinary project teams.
• Strong team‑oriented mindset, structured and organized working style, and proactive problem‑solving attitude.

Required skills

• Expertise in Computer System Validation (CSV).
• Good understanding of GAMP5 and CFR Part 11 requirements.
• Knowledge of Trackwise (Spring25 or later) QMS module.