Qualification & Validation Engineer – Life Sciences (DE)

Qualification & Validation Engineer – Life Sciences (DE)

  • Person in charge of Qualification/Validation activities: production equipment and / or utilities & HVAC, environment, cleanroom.
  • Qualification phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities.
  • Qualification Master plans are up to date and established for all ongoing projects.
  • Plan, coordinate and execute all phases for qualification of GMP manufacturing systems including but not limited to, Qualification plans, FMEA, DQ, IQ, OQ, PQ.
  • Prepare, review and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification documentation).
  • Coordinate and execute FAT/SAT, commissioning activities for new manufacturing systems in collaboration with internal and external partners.
  • Coordination and oversight of external suppliers.
  • Must have : GMP knowledge
  • Must have : Bachelor / Master’s degree in pharmaceutical or biotech related industries.
  • Above 3 years of experience in qualification and validation
  • Languages: English and/or German
  • On-site work in cities: Bern, Zurich, Basel, Schaffhausen
Informations sur l’offre
27/02/2024
Zurich