Flexible & Integrated Technical Services, LLC

Responsible for developing, qualifying, and implementing Ethylene Oxide sterilization processes in accordance with ISO 11135 and international standards. This includes managing communications with contract sterilizers and supporting environmental monitoring for cleanroom manufacturing.

Lead and manage the full sterilization project portfolio, including validations, process improvements, and new product launches. Serve as a subject matter expert for EO sterilization processes while coordinating with external service suppliers and internal stakeholders.

The role involves managing the Approved Supplier List for distributors and 3PLs, negotiating quality agreements, and executing audit schedules. It also includes providing quality engineering support for new product development and ensuring suppliers meet GMP and quality standards.