• 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
• 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.