Reprocessing Scientist- Med Device Mircobiology
Core
Provide scientific leadership and guidance on medical device reprocessing and microbiology testing programs, serving as a technical subject matter expert for audits and client interactions.
Role type
Senior IC reprocessing scientist (microbiology)
Builds
Medical device reprocessing and microbiology testing programs
Domain
Medical devices + Microbiology
Required skills
Medical device reprocessing expertise, Microbiological testing (antimicrobial efficacy, sterility, sub-visible particle analysis, bioburden, MLT, CCIT, endotoxin), Cleanroom operations, Regulatory standards interpretation (GMP, GLP, USP, ISO), Scientific study design, Technical writing, Process improvement (Lean, Six Sigma), Instrument qualification (IQ/OQ/PQ)
Preferred skills
Leadership, Cross-functional collaboration, Problem-solving
Technologies
ELN, LIMS
Responsibilities
Serve as technical subject matter expert for internal and external audits, Provide scientific leadership on reprocessing and microbiology testing, Support method development, validation, and troubleshooting, Communicate complex technical information to clients and regulatory bodies
Seniority
Senior, hands-on IC