Commissioning & Qualification Engineer (M/W/D)
Responsabilities:
- Coordinate and conduct equipment qualifications, validations, and lifecycle activities including purchasing, maintenance, and decommissioning of analytical instruments
- Perform system validation (SDLC) in collaboration with IT and the site validation unit
- Support calibration and maintenance of analytical equipment in alignment with the Laboratory Asset Management Program (LAMP)
- Support site-wide Metrology & Validation projects and AR&D initiatives
- Author SOPs, change controls, periodic review documents, and support deviation investigations
- Check and evaluate alarms of controlled-temperature units (e.g., stability chambers) and lab equipment
- Coordinate with cross-functional teams to ensure timely delivery of qualification and validation activities
- Work independently and collaboratively within a dynamic team while maintaining GMP compliance
Qualifications:
- Technical education (apprenticeship or degree) in biotechnology, pharmaceutical sciences, IT, or related fields
- Strong communication skills in English (B1) and German (B2) – verbal and written
- High attention to detail with strong documentation skills
- Experience in Commissioning & Qualification (C&Q) and/or Computer System Validation (CSV)
- Ability to take initiative, solve problems, and coordinate with cross-functional teams
- Experience with GMP laboratory environment, controlled-temperature units, and analytical instrumentation is an advantage
- Affinity for technical maintenance of equipment and IT-related software
- Experience with Change Management, Deviations, CAPA, auditing, and compliance is a plus
- Proficient in Microsoft applications (MS Office)
Framework data:
Start: 12.01.2026
Duration: 12 Months
Capacity: 5 Days per week
Location: Werthenstein, Switzerland