Job Description
Job Description
Role: Sterilization Microbiologist
Location: Plymouth, MN 55442
Duration: 12 Months
Shift Timings: 8:00 AM to 4:30 PM
Looking for:
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Provide individual support for specific product lines.
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Must have knowledge of medical device manufacturing in a cleanroom environment.
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While cleanroom entry is not required, a basic understanding of cleanroom operations is essential.
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Responsible for assessing cleanroom impacts due to process changes, such as product line relocation.
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Should be familiar with ISO classifications, especially ISO 14644 (Cleanrooms and Associated Controlled Environments).
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Understand contributors to elevated particulate levels, and increased viable surface or air contamination.
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Must understand product-related risks, such as bio-burden and endotoxin, and how supplier changes could affect them.
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Assess and evaluate risks associated with onboarding new suppliers for components.
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Products involved are sterilized using ethylene oxide (EO); a basic understanding of EO sterilization is important.
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This is a desk-based role; no laboratory work or testing will be required.
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Role involves technical writing and communication with cross-functional teams.
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Experience with medical devices, cleanrooms, and laboratory environments is preferred.
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Looking for candidates who can start soon.
Education:
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Bachelor’s degree in a Science-related field.
Experience:
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Minimum 5+ years of relevant experience.
Interview Process:
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In-person interview required.
Top Skills:
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Prior experience in medical device manufacturing.
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Knowledge of cleanroom environments.
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Understanding of different ISO classifications.
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Familiarity with bioburden and endotoxin testing—candidate will not perform testing but must assess changes that could impact product bioburden/endotoxin levels and subsequently affect EO sterilization efficacy.