Insulet Corporation Sr. Sterilization and Microbiology Engineer in Acton, Massachusetts
The Sr. Sterilization/ Microbiology Engineer will be responsible for the sterility assurance and environmental monitoring programs for medical device sterilization, microbiology and related product and manufacturing process controls. This role will lead the 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
Manages EO Sterilization Validations, Out of Tolerance Investigations, Bacterial Endotoxin Testing
Provide direction and oversight of Sterilization Technology functions, including industrial sterilization, microbiological/environmental services, and new product development, across all business units.
Provide oversight, guidance, and support in the establishment of specifications/procedures related to sterilization, microbiological control and new product development.
Has a working with the following standards N ISO 11135-1:2007 – Sterilization of healthcare products – Ethylene oxide, EN ISO 11137-1:2006 – Sterilization of healthcare products – Radiation, ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories [Biotest Labs].
Prepares/Approves departmental documentation (Insulet Work Instructions, test protocols, validation documents, technical reports, etc.) for review and approval
Provides technical guidance to internal and external customers on issues pertaining to microbiology, clean room technology, instrument reprocessing, and industrial sterilization
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
Develop, document, and approve sterilization/ microbiology processes, procedures, work instructions, and/or forms
Conduct laboratory investigations, root-cause analysis, and corrective action implementation. Provides leadership and technical expertise for effective Root Cause Analysis
Establishes trends; recommends revisions to monitoring program and/or manufacturing process controls. Ensures effective corrective actions are implemented, where necessary.
Perform routine sterilization record review
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
Bachelor’s Degree in Microbiology, Biology or related science field
Minimum 5 years of medical device or pharmaceutical microbiological or biological testing, or research and development experience that includes product sterilization experience
Demonstrated knowledge of endotoxin and bioburden testing
Applied knowledge of microbiological and sterilization concepts, practices, and procedures
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
- Ability to lift up to 10 pounds.
External Company Name: Insulet Corporation
External Company URL: http://www.myomnipod.com/