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:

: 12.01.2026