Compliance Engineer | Chemieingenieur (m/w/d)
BioNTech SE
Job Summary
As a Compliance Engineer, you will play a crucial role in ensuring the GMP-compliant operation of facilities within your scope of responsibility, as well as the GxP-compliant execution of various central tasks. This involves maintaining and implementing internal quality assurance guidelines for the pharmaceutical industry within the Engineering and Maintenance department. You will be responsible for creating, reviewing, approving, and tracking GMP-relevant documents and measures, such as those for qualification, validation, periodic reviews, and SOPs. The role also includes independently analyzing errors, designing and implementing test scenarios, and executing projects while adhering to GxP and quality assurance requirements. You will continuously align current states with target states based on regulatory and quality assurance guidelines, participate in audits and inspections as a Subject Matter Expert, and perform continuous risk identification and assessment. This position offers the opportunity to contribute to internal and external projects, ensuring high standards of compliance and quality in a regulated environment.
Required Skills
Education
University degree (Dipl.-Ing. TU/FH, B.Sc./M.Sc.), ideally with a focus on Chemical Engineering or Biotechnology
Experience
- • 4-5 years of professional experience in compliance, ideally within the regulated pharmaceutical industry
Languages
Additional
- Not specified
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