Sr Microbiologist-Sterili Supv
Core
Sr Microbiologist-Sterility Supervisor leading sterility assurance, microbiology, and environmental control programs for medical device manufacturing.
Role type
Senior IC microbiologist (sterility assurance) with supervisory responsibilities
Builds
Sterility assurance programs, validated sterilization processes, and cleanroom environmental controls
Domain
Medical device manufacturing / Sterilization and Microbiology
Required skills
Sterilization validation, Microbiology principles, Cleanroom operations, Ethylene Oxide (EO) and Radiation sterilization methods, Bioburden testing, Bacterial Endotoxin testing, Root cause analysis, ISO 13485 quality systems, CAPA management, Team leadership
Preferred skills
Advanced English proficiency, Experience with international standards (ISO 11135, 11137, 11737, 10993, 14644, 14698, 17025), Methodology transfer from R&D
Technologies
Ethylene Oxide (EO) sterilizers, Radiation sterilizers (GAMMA, Ebeam), Automated analytical instrumentation, Environmental monitoring systems
Responsibilities
Analyze chemical, biological, or microbiological products and samples; Prepare, clean, disinfect, and sterilize instruments and supplies; Develop and validate controlled environment methods; Coordinate EO cycle qualification and requalification; Lead new product transfers and introductions; Conduct sterilization and microbiology impact assessments; Manage a team of technicians and engineers; Generate and investigate nonconformances and CAPAs; Support internal and external audits and regulatory submissions.
Seniority
Senior, hands-on IC with supervisory duties