Sterilization and Microbiology Specialist
Core
Establish and monitor cleanroom protocols (ISO7/ISO8), validate sterilization cycles, and release final medical device products for distribution.
Role type
Sterilization and Microbiology Specialist
Builds
Engineered components and sub-systems for minimally invasive surgery, robotics, and 3D metal printing
Domain
Medical device manufacturing / Sterilization
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microbiology knowledge, Sterilization of medical devices, ISO 14644/11135/14971 standards, Quality tools (5Why, Ishikawa, 8D), SAP system proficiency, Technical documentation review
Preferred skills
Higher education in natural sciences (microbiology, molecular biology, biochemistry), Experience with new product introduction
Technologies
SAP, MS Office
Responsibilities
Monitor cleanroom environments and evaluate bioburden trends, Validate sterilization cycles and resolve deviations, Approve release of final products for distribution, Conduct revalidation of cleanrooms and assess implemented changes, Train employees on cleanroom management, hygiene, and sterilization, Represent the company during internal/external audits
Seniority
Mid-level, hands-on specialist