This position will be partially responsible to assure products manufactured or distributed by Bard Access Systems comply to recognized industry, federal microbiological and sterility standards. This position has responsibility to ensure division and external suppliers conduct microbiological testing, sterilization and environmental monitoring activities according to regulatory expectations and industry standards. Bard Access Systems is an Equal Opportunity Employer.
The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.
1. Serves as division Microbiology Expert to support ISO certification and CE marking
2. Assists in division policies, procedures and systems to assure compliance with industry, federal recognized standards and regulations and Corporate policies and guidelines for
- microbiological testing of raw materials, components, in-process and finished devices
- development and validation of sterilization equipment and processes including contract sterilization
- environmental monitoring and microbiological control of manufacturing sites
- sterilization of medical devices
3. Defines requirements for and supports or conducts component supplier audits for sterilization, environmental monitoring and microbiological control procedures and systems
4. Defines requirements for, recommends, and supports audits of outside sterilization facilities and microbiological laboratories and serves as their primary division contact
5. Assists division employees on sterilization, environmental monitoring, and microbiological testing as required to support design and process controls for new product development and routine production
6. Provides input and direction for sterilization and microbiological laboratory service supplier contracts
7. Serves as plant microbiologist, where applicable, to specify facility requirements to meet environmental control specifications
This position requires:
- a Bachelor degree in microbiology or engineering with 4 (four) year of engineering experience within the medical device or equivalent regulated industry OR
- Masters degree with 3 (three) years of engineering experience within the medical device or equivalent regulated industry OR
- Demonstrated knowledge of engineering principles through 15 (fifteen) plus years of engineering experience within the medical device or equivalent regulated industry
The above experience must include demonstrated effective project management skills
Position requires 3+ years experience sterilization experience (ETO) in a medical device environment.