Bio-Operator (GMP Environment) | Bio-Operator (m/w/d) im GMP-Umfeld
expertum GmbH
Job Summary
This role involves operating sterile and cell culture technology machinery within a GMP-regulated environment. The Bio-Operator will be responsible for conducting various filtrations and manufacturing biopharmaceutical active ingredients according to cGMP guidelines, ensuring meticulous documentation of the production process. Key tasks also include the cleaning and sterilization of equipment, independent management of cell culture fermentation and filtration systems, and coordination of team activities with adjacent production units. Ideal candidates will possess a relevant vocational or scientific background, extensive knowledge of cGMP requirements, particularly regarding plant design and data integrity, and a strong understanding of hygienic work practices. This position requires a high degree of independence, organizational skills, and a commitment to quality and safety, including willingness to work in a 2-shift system with weekend shifts.
Required Skills
Education
Completed vocational training as a Bio-Specialist, Production Specialist for Biotechnology/Chemistry, Pharmaceutical Technician, Chemical Technician, or related fields in large-scale production; or a scientific education or comparable qualification (e.g., Brewer, Maltster, Dairy Specialist, Baker)
Experience
- Several years of professional experience, ideally in a GMP environment
- In-depth knowledge of cGMP requirements, especially regarding plant design and data integrity
- Experience with DV systems (e.g., MES, PLS, Labware)
Languages
Additional
- Willingness to work in a 2-shift system including weekends and participate in flexible assignments.
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