A propos de l'annonce

Description de la mission • 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 Des déplacements sont à prévoir pour ce poste : Mobility to be on clients site during the project is required, primarily in Switzerland, overnight stays possible depending on projects and candidates preference. Profil recherché • 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 German with good knowledge of English