Sterilization Engineer

wlgore; Flagstaff (AZ); Hybrid; USD 70,000 - 90,000; Full time

Job summary

wlgore is looking for a Sterilization Engineer to manage sterilization programs for both commercial products and new product development. This position is based in Flagstaff or Phoenix, Arizona, with potential for hybrid work. The ideal candidate will have strong technical support skills for sterilization processes in a regulated industry.

Responsibilities include supporting sterilization initiatives, interacting with contract facilities, and ensuring compliance with industry standards. Qualifications include a Bachelor's degree and experience with validation processes. This role involves collaboration across teams and occasional travel.

Qualifications

• Bachelor’s degree in engineering, microbial science, or relevant science degree.
• Experience with process validation, particularly performance qualification (PQ).
• Strong verbal and written communication skills.

Responsibilities

• Provide technical support for sterilization processes ensuring compliance.
• Interact with contract sterilizers for resolution of non-conformances.
• Analyze data and implement process changes.
• Document work with protocols and quality system documents.

Skills

Experience in a regulated industry

Communications skills

Troubleshooting complex problems

Project management

Education

Bachelor’s degree in engineering or relevant science

Job description

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
• Conduct periodic requalification of existing sterilization processes
• 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
• Partner cross‑functionally to support sterility assurance activities, providing solutions that reflect an understanding of business strategy, objectives, and cost implications

Required Qualifications

• 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

Learn more at gore.com/careers/benefits

Gore is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a protected veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.

Gore is committed to a drug‑free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.

Gore requires all applicants to be eligible to work within the United States. Gore generally will not sponsor visas unless otherwise noted on the position description.