Qualification Specialist (m/w/d)

Do you enjoy working in a structured and meticulous way and want to ensure quality in technical systems? At the Bioprocessing Systems Team in Guxhagen, you will provide documentation, data, and processes necessary for the testing and qualification of facilities. You will assist internal departments and customers in complying with legal requirements and contribute to making better health more accessible to more people.

• Create, maintain, and review documentation for production and quality, particularly test documents for Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), and re-tests.

• Collaborate closely with internal departments to ensure clear information flow.

• Support qualification engineers in the preparation and documentation of qualifications, such as test references, Quality Test Record (QTR), Validation Master Plan (VMP), documentation checks, and reports.

• Continuously improve processes, documents, and workflows and participate in projects across departments.

• Advise other departments on issues related to qualification and validation, and provide internal training on test documentation and Good Documentation Practice.

• Maintain qualification-relevant information and documents and handle internal quality notifications.

• Completed scientific or technical education

• Good technical understanding

• Proficient in Microsoft Excel and confident with common software

• Structured and meticulous working style including strong problem-solving skills

• Excellent communication skills and team spirit in a cross-disciplinary environment

• Analytical thinking and high-quality awareness

• Ideally, experience with documentation and process requirements in a regulated environment

• Proficient in German and English, with effective verbal communication skills

📈 Personal development through mentoring, leadership programs, talent discussions, and internal seminars

🏠 Home office options, flexitime, and flexible working hours

💶 Holiday and Christmas bonuses as well as pension benefits

⏰ 37.5-hour workweek and 30 vacation days

🚗 Car leasing, bike leasing, a large free car park, and good bus connections

👶 Subsidies for childcare costs and additional care insurance as well as an offer for disability insurance without health checks

🏖️ Annual choice between five additional vacation days or a special payment

🌍🌈 We welcome applications from people of all backgrounds and look forward to receiving your compelling application. 🌈🌍