Qualification Engineer | Qualification Engineer (x/w/m) bei Sartorius
Piening GmbH (Göttingen)
Job Summary
As a Qualification Engineer at Sartorius, you will play a crucial role in ensuring the regulatory compliance and operational readiness of pharmaceutical production facilities. Your daily tasks will involve creating comprehensive test documentation, including IQ/OQ documentation, and ensuring adherence to GMP/GDP guidelines. You'll be responsible for approving testing and qualification documents, reviewing results, and managing technical documentation. The role also includes actively participating in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT), serving as the primary contact for qualification-related documentation inquiries, and developing robust test strategies. This position offers an attractive career path within a growing industry, providing long-term stability and opportunities for professional development within a supportive team environment at Sartorius Stedim Systems in Guxhagen, Germany.
Required Skills
Education
Completed degree in Process Engineering, Biotechnology, Automation Technology, or comparable education
Experience
- Professional experience in commissioning or plant qualification within the pharmaceutical industry
- Experience in testing or test fields is preferred
- Foundational knowledge of GMP/GDP, relevant guidelines, and standards
- Initial experience with IQ/DQ/OQ/PQ is a plus
Languages
Additional
- International travel readiness (approx. 30%)