Microbiologist (Onsite)

What you will do

• Support site sterility assurance activities in accordance with applicable FDA Quality System Regulation, ISO 13485, ANSI/AAMI, and ISO requirements for medical device sterilization and microbiological controls.
• Provide technical guidance for product sterilization and disinfection processes using ethylene oxide, vaporized hydrogen peroxide, steam, and other applicable sterilization modalities.
• Execute and support sterilization and cleaning validations, residual evaluations, and related studies to verify product sterility, cleanliness, and process effectiveness.
• Manage microbiological testing activities, including bioburden, bacterial endotoxin, environmental monitoring, and other product testing programs.
• Investigate sterilization, microbiological, environmental monitoring, and testing nonconformances and support implementation of appropriate corrective actions.
• Evaluate sterilization and microbiological requirements against current ANSI, AAMI, ISO, USP, FDA, EPA, and European regulatory standards and incorporate applicable changes into site processes.
• Partner with Quality Assurance, Operations, Product Development, suppliers, laboratories, and other stakeholders to resolve technical issues and maintain compliant sterility assurance processes.
• Identify and implement improvements to sterilization, testing, validation, and microbiological processes that support product quality and operational efficiency.
• What you need
• Required
• Bachelor of Science in Biology, Microbiology or a closely related life science.
• 3-5 years of medical device or pharmaceutical microbiological or biological testing, or research and development experience that includes product sterilization.
• Demonstrated knowledge of endotoxin and bioburden testing.
• Ability to cross-reference and keep current on relevant ANSI, AAMI, ISO, USP, EPA, EU and related guidelines.
• Demonstrated ability to work on cross-functional teams.
• Preferred
• Applied knowledge of microbiological and sterilization concepts, practices, and procedures. These include gamma irradiation and ethylene oxide forms of sterilization.
• Knowledge in analytical chemistry and cleaning validations.
• USN: $69,500 - $110,900 USD Annual