Qualification & Validation Engineer

nemensis ag

Luzern, SchachenFestanstellungVeröffentlicht 1.11.2026

Über den Job

For our client, a globally active pharmaceutical company running a high-tech development site in the Lucerne region, we are looking for a Qualification & Validation Engineer (m/w/d) who thrives under strict GMP standards.

Aufgaben

Own qualification and validation projects for lab instruments, equipment, clean rooms, utilities and facilities
Draft, review and execute validation documents such as protocols, reports and risk assessments
Oversee computer system validation (CSV) across manufacturing and quality areas
Ensure compliance with cGMP guidelines and regulatory expectations
Liaise with Production, Quality Control and Engineering on validation topics
Support internal and external audits and inspections
Review GMP documents incl. deviations, CAPAs and change controls

Profil

Degree in engineering, pharmacy, chemistry, biotechnology, microbiology or related field
5+ years of hands-on experience in qualification and validation, incl. CSV
Solid grasp of GMP/cGMP principles and regulatory expectations
Analytical mindset with strong documentation and problem-solving skills
Comfortable working independently and in cross-functional teams
Fluent in English and (min. B1)
Familiarity with GAMP5, Annex 11/15 and data integrity is a plus

Rahmenbedingungen

Assignment period: 01.12.2026 – 30.11.2027
Location: Schachen (LU)
Employment type: Temporary placement
Contact: Nemensis AG, Basel

Skills

Qualification & ValidationGMP/cGMP-StandardsComputer System Validation (CSV)Validations-Protokolle & Risk AssessmentLab-Instrumente & Equipment QualificationClean Room ValidationRegulatory ComplianceAudit-Support

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