Sterilization Engineer

Your Job

Phillips Medisize, a Molex Company is seeking a Sterilization Engineer to support our Global Technical Services Team in our Hudson, WI site and other Wisconsin locations.

This role will manage, organize, and coordinate the activities of Sterilization with the goal of maximizing company profitability by providing products/services that meet customer expectations at the lowest cost.

Support manufacturing in the effort to ensure optimum validation of projects/programs to meet customer, regulatory and manufacturing requirements.

Our Team

Phillips-Medisize, a Molex Company is an end-to-end provider of innovation, development, and manufacturing solutions to the pharmaceutical, diagnostics and medical device industries.

Our team at Hudson, WI is made up roughly of 300 employees that support our production, Engineering, Quality, Molding & Tooling departments.

This is a hybrid position that can be based out of Hudson, New Richmond, or Menomonie depending on where the individual resides.

What You Will Do



* Interpret and negotiate sterilization requirements to meet customer needs


* Act as a sterilization resource to partner with Sales, Cost Estimators, Purchasing and Business Development on quoting and sourcing programs with packaging materials and/or sterilization services and trade show support


* Set top-level project implementation deliverables and dates and manage the execution


* Identify software, hardware and equipment needs for sterilization operations


* Identify and monitor the supporting resources required for various stages of business implementation, on-going support of the sterilization operations and drive task-level management


* Partner with Customers, Quality/Validation/Manufacturing/Project Engineers and Program Managers to successfully transition programs from development to production


* Coordinate the transfer of contracted programs to Phillips-Medisize facilities


* Remain up to date on the latest trends and technologies in the sterilization industry


* Partner with Regulatory/Validation personnel related to Sterilization Management

Who You Are (Basic Qualifications)



* Bachelor's degree in Biochemistry or related engineering field


* 2+ years of experience in sterilization processes, validation, and/or medical device quality assurance


* Strong understanding of 21 CFR 820, 21 CFR 211, ISO 13485, and GMP practices


* Experience with specific sterilization methods such as ethylene oxide, gamma, steam, or vaporized hydrogen peroxide

What Will Put You Ahead



* Knowledge of microbiology related to sterilization processes is beneficial


* Experience with packaging validation and sterile barrier packaging


* Experience with any of the following regulations, standards, and guidance documents for Packaging and Sterilization: IEC 60601, ISO 15223-1, ISO 20417, ISO 17665, ISO 11135, ISO 11137, ISO 17664, ISO 11607, ASTM standards for test methods


* Pre...