Sterility Assurance Specialist

The sterility assurance specialist is responsible for multiple projects/tasks related to ensuring continued compliance with sterilization and product adoption requirements. The sterility assurance specialist will collaborate on cross functional teams to perform necessary teams to perform necessary tasks relating to product/process change evaluations, sterilization validations, product adoption, and assurance of sterility requirements. 

• Collaborate and approve product/process changes to ensure sterilization validation remains compliant. Request testing as needed. 

• Continues to develop knowledge in sterilization fields and stays current on industry changes or external concerns

• Support product development by perform product sterilization technical reviews/evaluations and adoptions

• Communications with cross functional teams to ensure complicance with applicable industry standards and support regulatory responses

• Monitor sterilization/ sterilization assurance processes to ensure they meet regulatory, QMS, and operational requirements

• investigates and initiates technical activities leading to new or improved sterilization processes to meet strategic goals and objectives

• performs and approves cycle/product reviews and requalifications

• Performs and approves routine sterilization load release

• Drive and direct continued improvement of sterility assurance operations

• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements
• Ability to work overtime as required
• Must strictly adhere to safety requirements

• Bachelor's degree in Engineering, Microbiology, Biology, or related field
• minimum of 5 years medical device or pharmaceutical experience
• Desired minimum of 2 years experience with Ethylene Oxide (EO) sterilization and/or other sterility modalities
• Excellent organizational and time management skills
• Desired knowledge in related industry standards; ISO 11135, ISO 10993-7, ISO, 111138, ISO/TS 19930
• Knowledge of Microsoft Word, Excel, and Outlook

Physical Requirements:

• Must be able to perform reasonable job functions requiring periods of sitting, standing, walking, hearing, and utilizes close visual acuity for working with computers, etc.
• Able to lift and/or move more than 50 pounds occasionally
• Personal protective equipment including respiratory protection, safety glasses, lab coat, gloves and appropriate shoes may be required in areas associated with this position