Commissioning & Qualification Engineer (m/w/d)

Project overview

Commissioning & Qualification Engineer (M/F/D)

Responsibilities

Qualification:

• 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.
• 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.

Nice to have

• 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).

Project details

01.12.2026

12 months

Capacity: 5 days per week

Werthenstein, Switzerland

• Start: ASAP
• Duration: 12 months
• Remote: hybrid
• Location: Werthenstein, Switzerland, CH