Sterilization and Microbiology Engineer

Employment Type

: Full-Time

Industry

: Miscellaneous



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The 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



Preferred Skills/Competencies:

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

At Advantage Resourcing, our primary objective is to perfectly align the best people with the appropriate jobs. These jobs may be temporary assignments or career positions. We place talented people in a wide variety of jobs working with our client companies in areas such as: engineering, IT, technical, manufacturing, skilled trades, distribution, call centers, clerical, accounting, finance and sales.

Our strength is being able to solve our client's workforce needs by matching people that have the right skills, knowledge and motivation to each opportunity. Advantage Resourcing can help you discover the personal and career success you desire.

Advantage Resourcing Americas, Inc. is an Equal Opportunity Employer offering employment without regard for race, color, religious creed, national origin, ancestry, gender, marital status, age, sexual orientation, sex, gender identity, disability, veteran status, or other legally protected categories. Advantage Resourcing is a VEVRAA Federal Contractor.
- provided by Dice

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