We are looking for a Computerized System Validation (CSV) Engineer to support validation activities for systems used in Good Manufacturing Practice (GMP) environments. In this role, you will help ensure that computerized systems are compliant, reliable, and meet both regulatory and business requirements.
The task and responsibilities will be to write and review validation plans (VP) and validation summary reports (VSR). Review and approve design documentation for compliance with system requirements and GMP guidelines. Write and review qualification protocols and reports, including Installation (IQ), Operational (OQ), and Performance Qualification (PQ). Monitor and support the execution of qualification and validation activities throughout the system lifecycle.
Skills and experience needed:
- Solid understanding of GMP regulations and relevant guidelines (eg GAMP, Eudralex Vol. 4 Annex 11, 21 CFR Part 11)
- Experience with validation methodologies and frameworks (eg V-model, ICH guidelines, ASTM E2500)
- Fluent in both English and French
- Prior experience in the pharmaceutical industry is a strong advantage