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- Waukegan, IL 60079
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Sterilization Specialist - NPS Waukegan
Medline Industries, Inc. • Waukegan, IL
Posted 1 month ago
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Medline Industries, Inc. has an immediate opening for a Sterilization Specialist for our Northpoint Services Division located in Waukegan, IL. The Sterilization Specialist will be responsible for preparing and executing sterilization related activities among various divisions, sterilization facilities and contract laboratories, scheduling and conducting all sterilization validation activities within NPS. We are seeking a hard-working, detail-oriented professional with experience in a medical device manufacturing/sterilization environment. In addition to exceptional leadership potential and analytical skills, you must have a “roll-up your sleeves” attitude.
- Prepare and execute sterilization activities for ethylene oxide and/or radiation sterilization among sterilization facilities. Prepare items for dose audit, sterility testing and bioburden testing and coordinate with contract laboratory and radiation facility. Maintain sterilization files and document libraries
- Prepare validation protocols and reports. Order micro-kits and dunnage and make sure they are shipped to appropriate sterilization vendor. Prepare purchase order and test request for contract laboratories for testing of the micro-kits. Review test results, run records, analyze temperature and humidity data to make sure they meet the acceptance criteria of the protocol and prepare a final report for approval.
- Assign sterilization cycles to new products based on the review of components, case density and packaging. Review the validated process to make sure the item can be sterilized in this process.
- Review and revise Sterilization procedures as needed when a new sterilization process is added or change in current process.
- Assist Northpoint Services division during validation preparation and train contract sterilization personnel and/or vendors on validation preparation. This at times may require lifting up to 50 lbs repeatedly and wearing full face respirator with supplied air tanks.
- Provide QA support to the division(s) as related to sterilization to maintain regulatory compliance including during internal and external audits.
Medline offers a business casual, entrepreneurial work environment with strong growth potential, a competitive compensation package, and a complete benefits package including medical/dental/vision/life insurance; 401(k) with company match. And much more!
- Bachelor’s degree with a scientific or engineering background required. Microbiology or engineering preferred.
- At least one 1 year Quality Systems experience in sterilization, medical devices, drugs or other FDA regulated industry preferred.
- Intermediate level skill in Microsoft Excel (for example: using SUM function, setting borders, setting column width, inserting charts, using text wrap, sorting, setting headers and footers and/or print scaling).
- Intermediate level skill in Microsoft Word (for example: inserting headers, page breaks, page numbers and tables and/or adjusting table columns).
- Must be willing to work safely in environments where hazardous chemicals may be encountered.
- Willing to travel up to 15% of the time for business purposes (within state and out of state).