Sterility Assurance Specialist I

The Sterility Assurance Specialist I at Cook Incorporated is responsible for multiple projects/tasks related to ensuring continued compliance with sterilization validation and product adoption requirements. The Sterility Assurance Specialist 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
• Develops 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
• 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
• Builds Process Challenge Devices, dunnage loads, and other duties assigned
• Support microbiology testing and/or projects

• Work closely with other functions to define projects and objectives when applicable
• 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 operations
• 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.
• Desired minimum of 1-2 years medical device or pharmaceutical experience

• 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)

Physical Requirements:

• 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