Sterilization Consultant

Canyon Labs exists to raise the standard of services in the Medical Device and Pharmaceutical markets by providing streamlined and expert solutions in technical consulting, sterilization, analytical testing and packaging. We are committed to ensuring that quality services are delivered by meeting or exceeding customer expectations, continuously improving the effectiveness of the quality system, and ensuring compliance with regulations, standards and directives. Location: Remote, US Salary Range: $90,000 - $100,000 Employment Type: Full-Time About the Role Canyon Labs is seeking a Sterilization Consultant to serve as a trusted technical advisor and subject matter expert in sterilization science, applied microbiology, and sterility assurance. This highly visible, client-facing role supports medical device and life sciences organizations by developing sterilization strategies, interpreting microbiological data, and providing guidance on regulatory and industry standards requirements. The ideal candidate combines strong scientific expertise with excellent communication skills and enjoys partnering with clients to solve complex sterilization and microbiological challenges throughout the product lifecycle. What You'll Do Serve as the primary technical contact for sterilization strategy, validation design, microbiological assessments, and regulatory consultation. Collaborate directly with clients to scope projects, explain study plans, and communicate scientific findings and recommendations. Evaluate product characteristics, sterile barrier systems, microbial risks, and intended use to recommend appropriate sterilization modalities, including ethylene oxide (EO) and radiation sterilization. Develop and review sterilization validation and requalification protocols, reports, and study plans. Design and interpret microbiological studies supporting sterility assurance, including: Bioburden testing and characterization Recovery efficiency studies Organism identification Biological indicator and resistance assessments Sterility testing when appropriate Analyze microbiological trends, investigate atypical results, and partner with laboratory and quality teams to assess product impact and recommend corrective actions. Support sterilization dose substantiation, cycle development, requalification activities, process changes, and ongoing monitoring programs. Review client protocols, reports, risk assessments, and regulatory support documentation for technical accuracy and scientific integrity. Collaborate across microbiology, sterilization, packaging, quality, and project management teams to ensure successful project execution. Prepare clear technical reports and participate in client meetings, technical reviews, and project discussions. What You'll Bring Education Bachelor's degree in Microbiology, Biology, Biomedical Engineering, or a related life sciences field required. Advanced degree in Microbiology or a related discipline preferred. Experience Minimum of 5 years of experience in sterilization, sterility assurance, or applied microbiology within the medical device, pharmaceutical, or biotechnology industries. Experience interpreting microbiological data and applying findings to sterilization validation and routine process decisions. Hands-on experience with at least one terminal sterilization modality (EO or radiation); experience with both is preferred. Experience authoring or reviewing technical protocols, validation reports, investigations, and regulatory support documentation. Proven ability to communicate technical findings effectively to clients and cross-functional stakeholders. Why Join Canyon Labs? At Canyon Labs, you'll work alongside industry experts dedicated to advancing the safety and effectiveness of medical devices and life sciences products. You'll have the opportunity to solve challenging technical problems, build strong client relationships, and make a meaningful impact on products that improve lives around the world. Canyon Labs offers several benefits as part of your total compensation, including but not limited to: Paid Time Off, Sick Time, and Paid Holidays Medical, Dental and Vision Insurance Long term disability insurance, life insurance 401(k) with company match up to 4% At Canyon Labs, we are committed to creating a diverse and inclusive workplace. We provide equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other protected characteristic under applicable laws. #J-18808-Ljbffr Canyon Labs