Biologielaboranten/BTA oder Chemielaboranten/CTA (m/w/d) für das Bioburden-Labor
Core
Conducting bioburden determination tests and method suitability tests for medical devices in ISO Class 6 cleanrooms according to Ph. Eur./USP/DIN EN ISO 11737-2.
Role type
Bioburden Laboratory Technician (BTA/CTA)
Builds
Microbiological monitoring and validation reports for medical device production hygiene
Domain
Medical device manufacturing / Analytical laboratory
Required skills
Microbiological methods, sterile handling, cleanroom operations, GMP compliance, laboratory instrumentation maintenance, process documentation, ISO 17025 standards
Preferred skills
Experience in cleanroom environments, method development, continuous improvement initiatives
Technologies
Ph. Eur., USP, DIN EN ISO 11737-2, ISO 17025, GMP
Responsibilities
Perform bioburden determination tests, execute method suitability tests, maintain laboratory equipment, document work steps according to GMP, develop and refine testing processes, collaborate on projects
Seniority
Mid-level, hands-on IC