Sr Sterility Assurance Scientist
Integra LifeSciences · Office, NJ +9 more
ResearchFull-time$71k–$98kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Integra LifeSciences seeks a Senior Sterility Assurance Scientist to serve as subject matter expert for sterilization compliance across manufacturing operations. The role involves maintaining regulatory adherence, supporting validations, training personnel, and consulting on sterility-related technical matters across multiple facilities.
What they're looking for
- Bachelor's degree in Microbiology, Biological Sciences, or Engineering
- 10+ years of experience with sterilization of medical devices or pharmaceuticals
- Working knowledge of ISO 11135, ISO 11137, and related sterilization standards
- Familiarity with FDA regulations and industry guidelines for sterilization and microbiological control
- Strong written and oral communication skills with cross-functional team collaboration ability
- Experience writing standard operating procedures, protocols, and test reports
- Analytical and critical thinking skills with attention to detail
What you'll be doing
- Serve as sterilization subject matter expert and maintain procedures across company sites
- Support EU MDR compliance through gap analysis and resolution planning
- Perform technical assessments of contract sterilizers and external supplier contamination controls
- Support sterilization, cleaning, and bioburden validations for all product families
- Train personnel on contamination control, sterilization requirements, and procedural changes
Privacy & handoff
This role links to Integra LifeSciences's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.