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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
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