Microbiologist (Onsite)

As the Microbiologist, you will support and ensure site Sterility Assurance and compliance to ANSI/AAMI/ISO, FDA Quality System Regulation, ISO13485 related to medical device sterilization, microbiology and related product and process controls.

In this onsite role, you will apply microbiology and sterilization expertise across product sterilization, validation, environmental monitoring, and testing activities while partnering with Quality, Operations, Product Development, and external laboratories and vendors.

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.