Job offer
Validation Engineer (GMP/CSV)
Consultant
Mission.
- Plan, execute, and review qualification protocols (IQ, OQ, PQ) for equipment, utilities, and facilities
- Perform Computer System Validation (CSV) activities in line with GAMP 5 guidelines
- Author and review validation documentation: VMP, URS, FS, DS, test protocols, and final reports
- Collaborate with cross-functional teams including QA, IT, production, and engineering
- Manage deviations and CAPAs related to validation activities
- Support regulatory inspections and internal audits from a validation perspective
- Ensure compliance with applicable regulations (FDA 21 CFR Part 11, Annex 11, EU GMP)
Required profile.
- Engineering or science degree (biomedical, chemical, pharmaceutical, or equivalent)
- Minimum 3 years of experience in validation within a GMP-regulated environment
- Strong knowledge of GAMP 5, FDA 21 CFR Part 11, and EU Annex 11
- Experience with CSV and/or process validation is a strong asset
- Rigorous, structured, and detail-oriented approach to documentation
- Fluent in English; French and/or Dutch is a plus