Required skills
- Qualification
- Validation
- GMP
- URS
- Risk Analysis
- FMEA
- Design Review
- DQ
- IQ/OQ/PQ
- Computerized System Validation (CSV)
- GAMP 5
- Veeva Vault
Languages: French
Job description
A pharmaceutical laboratory in Chartres is seeking an experienced Qualification/Validation Engineer to prove that new equipment complies with GMP before production. The role involves defining validation strategy, writing protocols, qualifying computerized systems, and managing changes.
Project overview
COFINOPS, a human-sized firm specializing in Finance, Purchasing, Supply Chain, and Quality, is looking for an experienced Qualification/Validation Engineer for an international pharmaceutical laboratory (Chartres production site).
The project: replacement of obsolete equipment (machines, automation, software) on a vial packaging line. Your role: to prove, with tests and supporting documents, that the new equipment complies with GMP before its production.
Your missions:
Conditions:
- Define the qualification strategy and write the validation plan
- Write/update URS and conduct risk analyses (FMEA)
- Participate in design reviews and DQ
- Write and execute IQ / OQ / PQ protocols (IV / OV / PV verification approach)
- Qualify computerized systems and automation (CSV, GAMP 5)
- Manage change requests in Veeva Vault, handle deviations and CAPA
- Write reports, update instructions, and train operators
- Start date: December 1, 2026
- Duration: 6 months, possible extension in 2027
- 100% onsite in Chartres, 5 days/week (1 hour by train from Paris-Montparnasse)
- Occasional weekends possible during implementation phases
- Reporting to the Project Manager, French and English speaking environment
Project details
- Start: flexible
- Remote: onsite
- Location: 28000 Chartres, France, FR
- Languages: French
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