Planning, execution, and documentation of qualifications (IQ/OQ) and calibrations of laboratory and production equipment in accordance with GMP, ISO, and GxP requirements

Performing qualifications, particularly in regulated production environments and in cleanrooms of classes ISO 7/8

Contributing to the preparation, maintenance, and optimization of quality-relevant documents such as qualification plans, reports, and SOPs

Supporting the implementation of new equipment—from requirement definition through design and commissioning phases to successful qualification

Supporting and contributing to risk analyses for the risk-based determination of qualification requirements

Close cross-functional collaboration with Quality Assurance, Production, Development, and Engineering to ensure a high level of compliance and quality

Supporting the preparation for audits and representing the department during regulatory inspections, as well as handling resulting actions

Successfully completed vocational training in a pharmaceutical, chemical, scientific, or technical field

Basic knowledge of relevant standards and regulations in the area of qualification and calibration, e.g. GMP guidelines, DIN EN ISO 17025, ISO 13485

Experience in the preparation or processing of qualification and/or calibration documentation in a regulated environment

Proficient in MS Office, ideally with initial experience in ERP systems and document management systems, e.g. MasterControl

Good written and spoken German and English skills