Process Validation Specialist

vor 2 Wochen


Basel, Basel-Stadt, Schweiz Prime Life Sciences Vollzeit

At Prime Life Sciences, we are strengthening our team in Switzerland with the addition of a Process Validation Specialist. As an expert in process validation for the life sciences industry, you will play a crucial role in supporting our clients achieve their projects.

Your Key Responsibilities
  • Qualify process equipment, utilities, HVAC, and lab equipment to ensure optimal performance.
  • Conduct thorough risk analyses to identify potential threats and develop effective mitigation strategies.
  • Create, review, and approve qualification reports, including FAT/SAT, Qualification Protocol (IQ, OQ, PQ), and test supervision.
  • Develop and implement process validation and cleaning process validation procedures.
  • Write risk analyses and AMDEC/FMEA documents.
  • Establish validation master plans and tests, as well as sampling plans.
  • Design key performance indicators (KPIs) for process monitoring.
Our Requirements
  • Masters degree in engineering or pharmacy.
  • First-hand experience in qualification or validation.
  • Familiarity with cGMP and ICH regulations.
  • Proficiency in English and German languages.

If you are looking for a new challenge and want to be part of a dynamic and multicultural team, we look forward to receiving your application.



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