Position Summary
This position will be critical to supporting Insulet's Global Sterility Assurance program. The Microbiologist role will primarily work within the QA Sterilization/Microbiology group performing various microbiological testing, including sample collection, bioburden testing, bacterial endotoxin testing, and environmental monitoring. This position will also support laboratory equipment qualifications, contract sterilization, and sterilization/test method validations.
Perform environmental monitoring of manufacturing areas (viable air, viable surface, and non-viable particulate testing).
Perform product bioburden and bacterial endotoxin testing.
Conduct quality control acceptance testing of microbiological media.
Use standard laboratory equipment including pH meters, microplate readers, balances, incubators, chart records, autoclaves, depyrogenation ovens, microscopes, vortexers, filtration systems, particle counters, air samplers, and pipettes.
Accurate completion of test records and documents for tests performed, as well as accurate computer data entry.
Support generation of procedures/work instructions related to sterility assurance.
Support microbiology laboratory investigations. Support activities related to microbiology nonconformances and CAPAs.
Perform routine sterilization record review. Support activities related to sterilization nonconformances and CAPAs.
Generate protocols and reports for sterilization qualifications and test method validations.
Conduct laboratory equipment qualifications, calibration, and preventive maintenance (as applicable).
Support quality audits, as required.
Education and Experience
Bachelor's Degree in Microbiology or related field with a minimum of 3 years relevant experience.
Prior experience working in the medical device or similar FDA-regulated industry is strongly preferred.
Must be proficient with general computer skills and Microsoft applications, specifically Word and Excel. Experience with statistical software programs like MiniTab is preferred.
Effective verbal communication and organizational skills.
Effective technical writing capability.
Must demonstrate great attention to detail and have ability to work efficiently.
Experience with basic microbiological laboratory techniques, including aseptic technique, and environmental monitoring.
Working knowledge of EO sterilization is strongly preferred.
Physical Requirements:
Ability to lift up to 10 pounds.

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