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Commissioning & Qualification Engineer (M/W/D)
Responsibilities
* 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
Seniority level
Associate
Employment type
Full‑time
Job function
Engineering and Information Technology
Industries
Staffing and Recruiting
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