Position Title
Corporate Sterilization & Microbiology Specialist
SBU
Corporate
Department
Quality Assurance
Relocation Covered
Potential
Educational Requirements
Bachelor's degree
Experience Requirements
Oversee all sterilization and microbiological methods and processes related to products designed and manufactured by client as well as products purchased by client. Review and approve sterilization cycle development, process validation, equivalency reviews, alternate sterilization methods and facilities, and microbiological controls. Evaluate new products, including custom or made-to-order kits, for impact of sterilization.
Qualification Requirements
Education- Minimum level of education needed to perform duties: BS or BA in a technical or scientific discipline. Extensive industry experience may be suitable substitution for a bachelor's degree.
Preferred Qualifications
Experience- Minimum experience needed, both inside and outside company, to perform duties: Minimum five years experience in bio-medical device or pharmaceutical industries. Minimum fives years experience in a sterilization and/or microbiology function commensurate with responsibilities outlined above. Knowledge and understanding of US, European and International standards, guidance documents and regulations related to sterilization and microbiological methods and controls. Experience with operation and validation of ethylene oxide, radiation or other methods of sterilization. Knowledge and understanding of quality system documentation requirements.
Responsibilities
Prepare and execute sterilization validation test, protocols and reports for all internal and external sterilization facilities. Evaluate impact of existing sterilization methods on new products or new product designs. Evaluate impact of existing sterilization methods on new or modified manufacturing-related changes. Evaluate impact of existing sterilization methods on custom or made-to-order kits. Evaluate alternative sterilization methods, facilities and processes as needed to support manufacturing objectives. Performs audits of internal and external sterilization suppliers according to a documented audit plan. Provide oversight, and ensure company-wide, consistent and compliant methods for the following: EtO residuals; bioburden monitoring; environmental monitoring; clean-room practices; and pyrogen testing. Train appropriate company personnel on sterilization and microbiological methods and processes as needed. Ensure company documentation related to sterilization microbiological controls are maintained and updated with most current regulations, standards and industry practice. Approve change control documentation (i.e., DMR) as sterilization/microbiology representative. Perform miscellaneous projects and duties at the direction of Quality Assurance and Manufacturing Management. Adhere to and ensure compliance to client code of conduct, all company policies, rules, procedures and house-keeping standards.
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