Operations Engineer / Technician, Pharmaceutical Production | Betriebsingenieur / Techniker (m/w/d) pharmazeutische Produktion im Raum München (1571)
Brüggen Engineering GmbH
Job Summary
This role is essential for ensuring that highly sensitive pharmaceutical production processes, including those for medications and diagnostic systems, adhere to the highest quality standards. As an Operations Engineer or Technician, you will serve as a technical expert responsible for the documentation, qualification, and continuous optimization of production facilities. Core responsibilities include managing complex biotechnological systems and fermentation processes (e.g., cell culture, harvesting, purification), executing GMP-compliant documentation, and overseeing safety standards. A key focus involves coordinating equipment qualification and validation (IQ/OQ/PQ), managing technical change requests according to cGMP guidelines, and performing necessary risk assessments in collaboration with quality departments. This position requires a background in Chemistry, Process Engineering, or Biotechnology and professional experience, ideally within the pharma/biotech industry, offering a critical role in maintaining operational excellence and compliance within a cleanroom environment in the innovative Munich pharmaceutical sector.
Required Skills
Education
Completed degree in Chemistry, Process Engineering, Biotechnology, or a comparable field OR qualification as a Technician in one of the mentioned areas.
Experience
- Professional experience in a comparable position, ideally in the pharmaceutical or biotechnological industry.
- Experience in GMP-compliant documentation, qualification, and validation of equipment.
- Experience in technical Change Management.
Languages
Additional
- Willingness to perform activities in a cleanroom.
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