Qualification & Validation Engineer (m/w/d)

About the role

Nemensis AG, a specialist recruitment partner for Life Sciences based in Basel, is recruiting a Qualification & Validation Engineer (m/w/d) for its client, a globally active pharmaceutical company operating a high-tech development site in the Lucerne region. The assignment runs from 1 December 2026 to 30 November 2027 in Schachen (LU) and is a temporary placement under strict GMP standards.

Key responsibilities

• 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 including deviations, CAPAs and change controls

Required profile

• Degree in engineering, pharmacy, chemistry, biotechnology, microbiology or a related field
• 5+ years of hands-on experience in qualification and validation, including 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 German (minimum B1)

Required skills

• GMP/cGMP knowledge
• Computer system validation (CSV)
• Familiarity with GAMP5, Annex 11/15 and data integrity is a plus

What we offer

• Comprehensive guidance and support through the application process from the consultants
• Access to a broad network of clients and positions across north-western Switzerland
• Fast onboarding with individual coaching and advice