euRHasi is recruiting for its client aCQV - Commissioning Qualification Validation Engineer (French/English).
Role:
Actively participate to CQV projects or activities definition, planning or execution.
Write project documentation (URS, Risk Analysis, Protocols, Reports, Traceability Matrix, )
Execute commissioning and qualification validation protocols; FAT, SAT, IQ, OQ, PQ.
Co-ordinate qualification execution activities, including external vendors, internal departments support, organizing materials, etc. Manage associated qualification deviations & CAPAs, including opening, resolution (with Supplier) and closure
Participate in the creation and review of process Risk Assessments
Profil
You hold a Master s degree in a scientific or engineering discipline
You have at least 3 years of experience in equipment commissioning, qualification, and validation (IQ, OQ, PQ)
You have some experience with black and/or clean utilities, HVAC or process equipment
You evolved in the Pharmaceutical and/or Biotech sector
You are competent with current FDA and EU regulations and best practices
You are fluent in French with good knowledge of English
Informations contractuelles
- Very competitive compensation package with exceptional Pension scheme
- 5 weeks paid holidays
- ongoing Training & Development opportunities.
Fluent in French with good knowledge of English Willingness to work in Switzerland You have at least 3 years of experience in equipment commissioning, qualification, and validation (IQ, OQ, PQ) Lifescience Industry experience