Senior Sterility Scientist

Integra LifeSciences

Sterility Assurance Scientist ensuring compliance across sterilization processes and methodologies in healthcare. Collaborating closely with various departments to maintain quality and regulatory standards.

Posted 7/20/2026full-timeCalifornia, Massachusetts, New Jersey, Utah • 🇺🇸 United StatesSenior💰 $71,000 - $98,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Sterilization Compliance, including knowledge of FDA, ISO, and EN standards, with a strong focus on maintaining and revising procedures for sterilization programs. Proficient in conducting gap analysis and formulating resolution plans to ensure compliance with regulatory requirements.

Highest-signal resume keywords

Sterilization ComplianceFDA RegulationsISO 13485Microbiology StandardsContamination Control

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

SterilizationMicrobiologyValidation ProtocolsStandard Operating ProceduresGap AnalysisRegulatory ComplianceContamination Control MeasuresTest Report WritingManufacturing ExperienceISO Documents Knowledge

Soft Skills

TrainingGuidanceProblem Solving

Tools & Technologies

Microsoft Office

Industry Keywords

Medical DevicePharmaceuticalFood IndustryCanadian Medical Device RegulationsEuropean Medical Device Regulation

About the role

Key responsibilities & impact

The Sterility Assurance Scientist is responsible for supporting activities that maintain compliance to the applicable regulations (FDA, Canadian Medical Device Regulations (CMDR), European Medical Device Regulation (EU MDR), ISO 13485, and ISO 9001) as they apply to sterilization
Maintains and revises procedures and methodologies to cover sterilization programs across sites
Obtains and maintains knowledge of FDA, ISO, and EN sterilization and related microbiology standards and guidelines
Supports EU MDR compliance by performing gap analysis and formulating gap resolution plans
Monitors and ensures adequacy of contamination control measures at external suppliers
Provides training to procedural changes
Provides guidance and input on the resolution of sterility related non-conformances
Creates and finalizes validation protocols and report ensuring they are clear, concise and compliant to work instructions and standards

Requirements

What you’ll need

A minimum of a Bachelor Degree is required
A Bachelor Degree in Microbiology, Biological Sciences or Engineering is preferred
Experience related to manufacturing and contamination control is preferred
Experience in sterilization/microbiology, medical device, Pharmaceutical and or / food industry is required
10+ years of experience working with sterilization of medical devices or pharmaceuticals
Have working knowledge of ISO documents related to sterilization such as ISO 11135 and 11137
Familiar with government regulations and Industry guidelines for sterilization and microbiological control
Working knowledge of applicable software, particularly Microsoft Office applications is required
Experience writing standard operating procedures, protocols, and test reports is preferred

Benefits

Comp & perks

medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
savings plan (401(k))