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

Job info

27/02/2024

Zurich