Responsable commissioning

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