Production Project Assistant | Projektassistent Produktion (m/w/d) - Ref.Nr.25L151
Microcoat Biotechnologie GmbH
Job Summary
This role is based at a growing biotech company specializing in diagnostic product development, manufacturing, and bioanalytical services. The Production Project Assistant will be responsible for the planning, organization, and manufacturing of test kits within a strictly regulated production environment (EN ISO 9001 and ISO 13485). Key daily tasks involve coordinating with internal departments such as logistics, quality control (QC), and quality management (QM). A significant part of the job includes handling QM-relevant topics like deviations, CAPAs (Corrective and Preventive Actions), and OOS (Out-of-Specification) results. The assistant will also execute equipment qualification and process validation, and be responsible for creating and optimizing manufacturing documents and Standard Operating Procedures (SOPs). Candidates should possess a relevant Bachelor's degree or a technical qualification (BTA/CTA) with professional experience, coupled with strong organizational skills and fluency in both German and English.
Required Skills
Education
Bachelor's degree in Biology, Biochemistry, Biotechnology, or equivalent; alternatively, a completed vocational training as BTA (Biological Technical Assistant) or CTA (Chemical Technical Assistant) with relevant professional experience.
Experience
- Professional experience in a regulated production environment (Biotech/Pharma) is implied for those with a BTA/CTA qualification
- Experience handling QM-relevant topics (deviations, CAPAs, OOS)
Languages
Additional
- The contract duration is temporary (BEFRISTET). Work must be conducted in a highly regulated production environment (EN ISO 9001 and ISO 13485).
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