Sterilization Specialist

Position Summary

Provide support for sterilization and microbiological methods and processes related to products designed and manufactured by Teleflex.  Evaluate new products and changes to product, including custom and made-to-order kits, for impact of sterilization. Responsible for the environmental control in Teleflex facilities. Lead and evaluate the microbiological tests performed to the product and the manufacturing areas. 

Principal Responsibilities

•    Provide support to maintain sterilization programs/policies for Teleflex Medical to endure all products and processes comply with the regulatory standards.
•    Ensure company documentation related to sterilization and microbiological controls are maintained and updated with most current regulations, standards, and industry practices.
•    Provide support to evaluate the impact/efficacy of existing sterilization methods on new products or new product / packaging designs. 
•    Provide support to evaluate and document the impact of new or modified manufacturing processes or environmental related changes on existing sterilization methods.
•    Provide support to evaluate the effectiveness of existing sterilization methods on custom or made-to-order kits.
•    Provide site support to ensure company-wide, consistent and compliant methods are followed for:  EO Residuals, bioburden monitoring, environmental monitoring, clean-room practices, and bacterial endotoxin testing. 
•    Develop procedures related to environmental control.
•    Establish limits for the bioburden, environmental monitoring of water and product.
•    Develop the protocols of microbiological qualification of new or modified manufacturing areas.
•    Coordinate routine sample collection for the product testing to ensure product/process controls are maintained in compliance with existing standards and procedures.
•    Perform miscellaneous projects and duties as directed by the immediate manager. 
•    Adhere to and ensure the compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures and housekeeping standards.

Education / Experience Requirements

•    B.S. or B.A. Degree in Biology, Chemistry, Microbiology, or other related science, or Engineering with strong chemistry or biology background is preferred.  Other B.S. or B.A. degrees will be considered.
•    Minimum of 1 - 3 years of experience in medical device industry (preferably).

Specialized Skills / Other Requirements

•    Knowledge / experience in EO and gamma radiation sterilization
•    Strong technical writing ability preferred
•    Statistical knowledge (DOE, SPC, Sample comparison, etc.) preferred
•    Strong communication skills (written and verbal)
•    Regulatory, cGMP, QSR knowledge base is preferred but not required
•    Computer literate (MiniTab, Word, Excel, etc.)
•    Negotiation and strong problem solving skills
•    Ability to communicate and operate effectively with multiple teams
•    Adapt to shifting priorities, work with minimal supervision, able to resolve problems/conflicts, reasoning ability