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Commissioning & Qualification Engineer (M/F/D)
Tasks:
Manage qualification and validation activities for Lab instruments, manufacturing equipment, clean room equipment, utilities, and facilities.
Prepare, review, and execute qualification and validation documentations, including protocols, reports, and assessments.
Provide oversight for computer system validation activities in manufacturing and quality environments.
Ensure all activities are performed in compliance with cGMP, regulatory requirements, and company standards.
Collaborate with cross-functional teams including Production, QC, and Engineering.
Support internal and external audits, inspections, and quality improvement initiatives.
Review GMP-related documents as required (e.g. Technical assessments, Deviations, CAPAs, Change Controls).
Contribute to continuous improvement of qualification and validation processes.
Qualification:
Bachelor’s degree in Engineering, Pharmacy, Chemistry, Biotechnology, Microbiology, or a related scientific discipline.
Minimum 5 years of experience in Qualification/Validation.
Strong working knowledge of GMP / cGMP principles and practices.
Hands-on experience in: - Qualification / Validation activities - Computer System Validation
Good understanding of regulatory expectations and quality systems in GMP area.
Strong analytical, problem-solving, and documentation skills.
Ability to work independently and collaboratively in a fast-paced environment.
English and German language proficiency at B1 level required.
Preferred Skills:
Experience in audit support and inspection readiness.
Experience in GAMP5, Annex 11 and Annex 15
Familiarity with data integrity requirements.
Good communication and stakeholder management skills.
Proficiency in MS Office tools and quality documentation systems (VeevaVault, Kneat).
Requirements:
Start: 01.12.2026
Duration: 12 months
Capacity: 5 days per week
Location: Werthenstein, Switzerland
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