Sterilization Specialist
On-site · Manchester, New Hampshire, United States
Job Summary
Sterilization Specialist to support and maintain the sterilization program for gamma and EO sterilized medical devices under ISO 13485 QMS; serve as internal SME for sterilization processes, validation activities, technical documentation, data interpretation, and regulatory compliance; coordinate with external contract sterilization providers; manage validation activities (dose audits, dose mapping, bioburden and sterility testing, verification dose experiments, product family assessments, packaging/material compatibility); review and interpret sterilization data and validation studies; ensure compliance with ISO 11137, ISO 13485, FDA QSR, GMP; support investigations, CAPA, audits, and regulatory submissions; liaison with vendors and cross-functional teams; travel occasionally for vendor/testing activities.
Required Qualifications
- Bachelor’s degree in Engineering, Microbiology, Biology, Chemistry, Life Sciences, or related technical field
- 3–5 years of experience in medical device, pharmaceutical, biotechnology, or regulated manufacturing environments
- Experience with gamma sterilization and sterilization validation activities preferred
- Familiarity with outsourced sterilization operations and external sterilization suppliers strongly preferred
- Experience working within ISO 13485 and FDA-regulated environments
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.