The Sterility Assurance Specialist II is responsible for multiple projects/tasks related to ensuring continued compliance with sterilization validation and product adoption requirements. The Sterility Assurance Specialist II will collaborate on cross-functional 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 performing product sterilization
technical reviews/evaluations and adoptions.
• Communicate with cross-functional teams to ensure compliance with
applicable industry standards and support regulatory responses.
• Monitor sterilization / sterility 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.
• Provides mentor-ship, training and support to Cook Inc. departments.
• Performs and approves cycle/product reviews and requalifications.
• Performs and approves routine sterilization load release.
• Work closely with other functions to define projects and objectives when
• Must work and interact effectively and professionally with and for others
throughout various levels of the global organization
• Must strictly adhere to safety requirements
• Maintain regular and punctual attendance
• Drive and direct continued improvement of Sterility Assurance
• Maintain company quality and quantity standards
• Must have effective oral and written communication skills
• Excellent problem solving skills and ability to work in collaborative and
independent work situations and environments with minimal supervision
• Ability to remain calm and receptive in fast paced situations
• Prepares reports, publishes, and makes presentations to communicate
findings and updates.
• Bachelor's degree in Engineering, Microbiology, Biology, or related field
• A 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
• Desired knowledge in related industry standards; ISO 11135, ISO 11737, AAMI TIR28, ISO 10993-7, AAMI ST72, ISO 11138, ISO/TS 19930
• A history of high performance demonstrating proficiency in several of the above listed job functions/duties preferred
• Dependent upon demonstrated proficiency, significantly skilled individuals lacking in the minimum length of experience or education listed
• Proficient in computer skills (excel, word, etc)
• Occasional travel may be required
• Must be able to perform reasonable job functions requiring periods of sitting, standing, walking, as well as those requiring manual dexterity, effective listening and communication
• Must be able to perform essential job functions
• Works under general office environmental conditions
• Personal protective equipment including safety glasses, lab coat and gloves required in certain areas associated with this position