Sr. Microbiologist - Sterlization
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About The Position
The Sr. Microbiologist- Sterilization position at Medtronic, Inc. in North Haven, CT involves analyzing chemical, biological, or microbiological products, raw materials, in-process materials, release test samples, or stability samples to support the company's quality program. The role includes preparing, cleaning, disinfecting, and sterilizing instruments, materials, products, and supplies. The candidate will interpret and evaluate analyses for accuracy and precision against established specifications and recommend corrective actions as necessary. Responsibilities also include coordinating laboratory and sterilization internal audit processes, managing Industrial Ethylene Oxide (EO) Sterilization for Medical Devices, and overseeing CAPA (Corrective Action Preventive Action). The position requires navigating various government and industry regulations, including FDA 21 CFR 820, ISO 11135, ISO13485, ISO11137, ISO11737, ISO 14644, and ISO 10993-7. Additionally, the candidate will coordinate Installation Qualification (IQ), Operational Qualification (OQ), Microbiological Performance Qualification (MPQ), Physical Performance Qualification (PPQ), and commissioning/re-commissioning for EO Sterilization Chambers, as well as sterilization adoptions and Radiation Dose Audits. The role leverages Good Manufacturing Practice (GMP), Aseptic Technique, Laboratory Information Management System (LIMS), Good Laboratory Practice (GLP), and Environmental Monitoring. The candidate will also be responsible for various product sampling for Bioburden and Bacterial Endotoxin testing. The position works a hybrid model and is required on-site at the North Haven, CT location 3 days a week.
