• Sterility Assurance Specialist

    Cook Medical (Bloomington, IN)


    Overview

     

    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.

    Responsibilities

    • 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

    Qualifications

    • 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

     

    Requisition ID2025-16967

     

    Posting Date4 days ago(7/29/2025 11:00 AM)

     

    Job Location(s)Bloomington IN United States

     

    Job LocationsUS-IN-Bloomington

     

    TravelNone

     

    Position TypeFull Time

     

    CompanyCook Inc - Bloomington

     

    CategoryEngineering