Bio-Operator (GMP Environment) | Bio-Operator (m/w/d) im GMP-Umfeld
expertum GmbH - Niederlassung Biberach
Job Summary
This role is for a Bio-Operator to independently manage and operate sterile and cell culture technology machinery within a GMP-regulated environment. Key responsibilities include performing various filtrations, manufacturing biopharmaceutical active ingredients under cGMP guidelines, and ensuring GMP-compliant documentation. The operator will also be responsible for cleaning and sterilizing equipment, overseeing cell culture fermentation and filtration systems, and coordinating tasks within the team and with adjacent production units. The ideal candidate will have a background in biotechnology, chemistry, or pharmacy, with significant experience in large-scale production, particularly within a GMP setting. Strong organizational skills, a high degree of quality and safety awareness, and proficiency with relevant IT systems are essential for success in this dynamic team environment.
Required Skills
Education
Completed vocational training as a Bio-Specialist, Production Specialist (Biotechnology/Chemistry), Pharmaceutical Assistant, Chemical Assistant, or related fields in large-scale production; or a scientific education or comparable qualification (e.g., Brewer, Maltster, Dairy Specialist, Baker) with several years of professional experience.
Experience
- Professional experience in large-scale productions, ideally in a GMP environment
- In-depth knowledge of cGMP requirements, especially regarding plant design and data integrity
Languages
Additional
- Willingness to work 2-shift system including weekends and participate in flexible assignments.
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