Responsibilities:

• Oversee all sterilization and microbiological methods and processes related to products designed and manufactured as well as purchased products labeled and sold.
• 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.
• Prepare and execute sterilization validations and test protocols/reports for all internal and external sterilization facilities.
• Provide support when evaluating the impact/efficacy of existing sterilization methods on new products or new product designs
• Evaluate the impact of new or modified manufacturing related changes on existing sterilization methods.
• Maintain and execute a sterilization and biocompatibility program/policy to ensure all products and processes comply with the regulatory standards.
• Provide input to creating strategies to assure compliance to regulatory standards regarding sterilization for products.

Requirements:

• B.S. Degree in B.S. in Biology, Chemistry, Microbiology, or other related science, or Engineering with strong chemistry or biology background.
• Knowledge / experience in EO and gamma radiation sterilization
• Regulatory, cGMP, QSR knowledge base
• Statistical knowledge (DOE, SPC, Sample comparison, etc.)
• Strong communication skills (written and verbal)
• Ability to communicate and operate effectively with multiple teams
• Negotiation and strong problem-solving skills
• Computer literate (MiniTab, Word, Excel, etc.)
• Ability to adapt to shifting priorities, work with minimal supervision, resolve problems/conflicts, and demonstrate solid reasoning ability