Senior Sterility & Compliance Scientist

Integra LifeSciences Corporation; Plainsboro Township (NJ); On-site; USD 71,000 - 98,000; Full time

Job summary

Integra LifeSciences Corporation is seeking a Sr Sterility Scientist to support sterilization programs, contamination control, and regulatory compliance. The role requires extensive experience with sterilization of medical devices and strong knowledge of ISO standards.

This position involves collaboration with Product Development, Regulatory Affairs, and Quality teams, and may require travel. The candidate should have a Bachelor’s degree in Microbiology or related field and at least 10 years in

Qualifications

• Bachelor degree in Microbiology, Biological Sciences or Engineering.
• 10+ years sterilization experience in medical devices or pharmaceuticals.
• Knowledge of ISO 11135 and ISO 11137 standards.

Responsibilities

• Serve as SME for sterilization across the company.
• Develop and revise sterilization procedures across sites.
• Support EU MDR compliance and gap analysis.
• Validate sterilization and cleaning processes with product development.
• Train staff on contamination control and sterilization requirements.
• Collaborate with QA, Regulatory, and Dev teams on sterility issues.

Skills

Bachelor's degree in Microbiology

10+ years sterilization experience

ISO 11135/11137 knowledge

Medical device/pharma contamination/mi

Microsoft Office

Education

Bachelor degree in Microbiology/ Biological Sciences/ Engineering

Job description

Integra LifeSciences Corporation is seeking a Sr Sterility Scientist to support sterilization programs, contamination control, and regulatory compliance. The role requires extensive experience with sterilization of medical devices and strong knowledge of ISO standards.

This position involves collaboration with Product Development, Regulatory Affairs, and Quality teams, and may require travel. The candidate should have a Bachelor’s degree in Microbiology or related field and at least 10 years in