Sterilization Engineer

About The Role

We are looking for a Sterilization Engineer to join our team. In this role you will provide support for Gore’s sterilization and microbiology programs encompassing both commercialized products and new product development, ensuring compliance with regulatory standards and industry best practices. This position will be located at our facility in Flagstaff, Arizona, or Phoenix, Arizona with the possibility of a hybrid work arrangement.

Responsibilities

• Provide technical support for contracted ethylene oxide, radiation and/or moist heat sterilization processes to maintain flow of commercial products
• Interact with contract sterilizers and test facilities, including resolution of non-conformances
• Analyze data and effectively implement process changes
• Document work with protocols, reports and quality system documents
• Develop and maintain knowledge of applicable industry standards for sterilization
• Support product sterilization needs through the product life cycle and new product development activities with sterilization evaluations, adoptions, and rationales
• Partner with other sterilization team members in Phoenix (AZ), Flagstaff (AZ) and Elkton (MD) to support sterilization initiatives and projects
• Partner with manufacturing, packaging, quality assurance, regulatory, and other functions/teams to support sterilization activities, including involvement in bioburden and environmental monitoring programs
• Prioritize, initiate and drive projects to completion
• Work effectively on an individual basis, within team situations and to collaborate with other functions
• Communicate, integrate and collaborate with remote sterilization team members
• Troubleshoot, resolve complex technical problems and drive continuous improvement efforts

Requirements

• Bachelor’s degree in engineering, microbial science, OR other relevant science degree
• Experience working in a regulated industry and within a quality system
• Experience with process validation and/or equipment validation activities, particularly performance qualification (PQ)
• Strong verbal and written communication skills including strong documentation skills, with attention to detail
• Hands on working style, with a strong sense of personal responsibility to meet commitments
• Ability to communicate, integrate and collaborate with remote sterilization team members
• Ability to prioritize, initiate and drive projects to completion
• Ability to work effectively on an individual basis, within team situations and to collaborate with other functions
• Ability to troubleshoot, resolve complex technical problems and drive continuous improvement efforts
• Ability to travel up to 10%

Desired Qualifications

• Experience in the medical or pharmaceutical industry
• Experience with moist heat, radiation, and ethylene oxide sterilization process validation, qualification, and applicable industry standards
• Knowledge regarding implementation of bioburden monitoring programs