Staff Scientist, Sterility Assurance

Position Summary

Oversee sterilization and microbiological methods and processes related to products designed and manufactured by Teleflex Medical, as well as purchased products labeled and sold by Teleflex Medical. Review and approve sterilization cycle development, process validations, equivalency reviews, alternate sterilization methods and facilities, and microbiological controls. Evaluate new products, including custom and made-to-order kits, for impact of sterilization. Lead resources required to ensure compliance and quality related to sterility assurance processes

Principal Responsibilities

• Execute/manage strategic projects related to sterilization/microbiolgy process changes or improvements
• Lead/assist/execute sterilization qualifications/annual requalifications for all internal and external Teleflex Medical sterilization facilities.
• Author/Review and /or approve drafted sterilization documents for completeness, correctness and compliance
• Complete Sterility Assurance plans, sterilization and microbiology assessments, protocols and reports as per regulary requirements.
• Address issues arising from sterilization non-conformances though to completion of the NC record.
• Evaluate impact/efficacy of existing sterilization methods on new products or new product designs. Act as sterilization expert for teams bringing new products to market.
• Evaluate the impact of new or modified manufacturing related changes on existing sterilization methods.
• Evaluate the effectiveness of existing sterilization methods on custom or made-to-order kits.
• Recommend and/or evaluate alternative sterilization methods, facilities, and processes as needed to support manufacturing objectives.

Long Description

• Maintain and assist in managing the sterilization program/policy for Teleflex Medical to ensure all products and processes comply with the regulatory standards.
• Support controlled environmental areas installation and qualification activities including protocol and report completion/review and approval with the applicable manufacturing sites.
• Liase with the manufacturing sites to ensure the procedures for environmental testing, product testing are compliant.
• Ensure microbial test methods are validated with the applicable laboratories.
• Create strategies to assure compliance to regulatory standards regarding sterilization for Teleflex Medical products.
• Provide sterilization expertise during 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: EO Residuals, dose audits, dose setting, dose mappings, dose augmentations, bioburden monitoring, environmental monitoring, cleanroom practices, and bacterial endotoxin testing. (These are considered “microbiological methods”.)
• Train appropriate company personnel on sterilization and microbiological methods and processes as needed.

Long Description

• Lead  technical interactions with  key stakeholders, customers, manufacturing associates, engineers, and service providers.
• Ensure company documentation related to sterilization and microbiological controls are maintained and updated with most current regulations, standards, and industry practices.
• Complete gap assessments of current procedure to ensure compliance to current regulations, standards, and industry practices.
• Perform miscellaneous projects and duties at the direction of Quality Assurance and Manufacturing Management.
• Adhere to and ensure the compliance of Teleflex Medical Code of Conduct, all company policies, rules, procedures, and housekeeping standards.
• Provide support to in-house microbiology and chemistry labs to provide efficient and compliant work processes (if applicable).
• Develop/Maintain Procedures, templates, best practices to support department day to day activity in an efficient manner.
• Identify, lead and implement continuous process and procedure improvements.

Education / Experience Requirements

• B.S. Degree in Biology, Chemistry, Microbiology, or other related science, or Engineering with strong chemistry or biology background and 10 years of experience in sterilization of medical devices
• M.S. Degree in Biology, Chemistry, Microbiology, or other related science, or Engineering with strong chemistry or biology background and 3 years of experience in sterilization of medical devices
• Minimum of 3 years of cross functional team leadership

Specialized Skills / Other Requirements

• Expertise and extensive knowledge in EO and radiation sterilization
• Regulatory, cGMP, QSR knowledge base
• Statistical knowledge (DOE, SPC, Sample comparison, etc.)
• Supplier audit skills
• Computer literate (MiniTab, Word, Excel, etc.)
• Strong communication skills (written and verbal)
• Ability to communicate and operate effectively with multiple teams
• Negotiation and strong problem solving skills
• Ability to manage multiple tasks in order to meet/exceed deadlines
• Proven ability to adapt to shifting priorities, work with minimal supervision, to resolve problems/conflicts, and demonstrate sound reasoning ability
• Ability to effectively lead a team in order to meet project timelines #LI-CM1