Qualification & Validation Engineer

nemensis AG; Schachen; On-site; EUR 55,000 - 96,000; Part time

Job summary

nemensis AG is seeking a Qualification & Validation Engineer (m/w/d) to drive qualification projects for lab instruments, equipment, clean rooms, utilities and facilities. You will draft validation documents, perform risk assessments and oversee CSV across manufacturing and quality areas.

The role requires a degree in engineering or life sciences, 5+ years of hands-on qualification/validation experience, and fluency in English and German.

Qualifications

• 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 German (min. B1).
• Familiarity with GAMP5, Annex 11/15 and data integrity is a plus

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 incl. deviations, CAPAs and change controls

Education

Engineering degree

Pharmacy degree

Chemistry degree

Biotechnology degree

Job description

Qualification & Validation Engineer (m/w/d)

Shape the Future of Pharmaceutical Quality (m/w/d)

• Employment type: Temporary placement

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.

• 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

Your profile

• 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 German (min. B1)
• Familiarity with GAMP5, Annex 11/15 and data integrity is a plus