Qualification Specialist

In the Bioprocessing Systems team, you take on an important role in providing qualification-related documentation, data and processes for FAT, SAT and requalification activities, and help ensure the quality and compliance of the systems. Location: Guxhagen.

• Support the creation, maintenance and review of production- and quality-related documentation, especially test documents for Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT) and re-tests
• Work closely with internal interfaces and ensure transparent information flow between the departments involved
• Support the qualification engineers in preparing and documenting qualification activities, including test references, Quality Test Record (QTR), Validation Master Plan (VPR), documentation reviews and completion of reports.
• Contribute to continuous improvement of processes, documentation and workflows and support cross-department projects
• Support other departments with questions on qualification and validation and run internal training on test documents and Good Documentation Practice
• Maintain qualification-related information and documents and handle internal quality reports

• Successfully completed scientific or technical vocational training
• Good technical understanding
• Knowledge of Microsoft Excel and confident use of common software applications
• Structured and careful way of working and strong problem-solving skills
• Strong communication skills and team orientation in an interdisciplinary environment
• Analytical thinking and a high awareness of quality
• Ideally experience with documentation and process requirements in a regulated environment
• Good English skills and conversational German skills, spoken and written