Senior Microbiologist
Edwards Lifesciences · USA IRV-3009 Daimler
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Role summary
Edwards Lifesciences seeks a Senior Microbiologist to provide technical leadership for sterilization, sterility assurance, antimicrobial control, and environmental monitoring programs in medical device manufacturing. The role involves leading validation studies, developing microbiological protocols, performing data analysis, and ensuring regulatory compliance across laboratory and manufacturing operations.
What they're looking for
- Bachelor's degree in Microbiology or related field with minimum 4 years regulated laboratory experience
- Master's degree in Microbiology or related field with minimum 2 years progressive microbial experience
- PhD in Microbiology or related field with minimum 1 year industry experience
- Advanced knowledge of ISO microbiological and sterilization standards
- Expertise in bioburden, sterility, endotoxin, and antimicrobial testing methods
- Proficiency with aseptic techniques and microbiological laboratory equipment
- Strong working knowledge of FDA QSR, GMP, and regulatory compliance requirements
What you'll be doing
- Lead microbiological testing activities including bioburden, sterility, endotoxin, and environmental monitoring programs
- Perform data analysis, trend evaluation, and provide authoritative guidance on atypical or ambiguous microbiological results
- Lead validation, qualification, and ongoing monitoring of critical systems including cleanrooms and manufacturing utilities
- Author, review, and approve standard operating procedures, protocols, and microbiological reports
- Lead investigations into out-of-specification results, out-of-trend data, and sterility failures with root cause analysis
Privacy & handoff
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