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Integra LifeSciences · 1 day ago

Sr. Sterility Assurance Scientist

Mansfield, MA

Full-time

Onsite

Mid, Senior Level

$82K/yr - $113K/yr

Integra LifeSciences is a company dedicated to innovating treatment pathways to enhance patient outcomes in healthcare. They are seeking a Senior Sterility Assurance Scientist to serve as a Subject Matter Expert for sterilization, maintain procedures, ensure compliance with standards, and provide training and guidance on sterility-related issues.

BiotechnologyHealth CareLife ScienceMedicalMedical Device

H1B Sponsor Likely

Responsibilities

Serves as a Subject Matter Expert for Sterilization across the company

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, for example knowledge on ISO 11137, ISO 11135 and environmental monitoring requirements

Supports EU MDR compliance by performing gap analysis and formulating gap resolution plans

Subject matter expert with regard to technical assessments of contract sterilizers and laboratories

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

Supports sterilization validations, cleaning validations, and supporting activities for all product families by setting company policy and direction for these activities

Works with product development to ensure timely and complete sterilization adoptions and validations of all new products including the introduction of new novel sterilization processes

Trains Product Development personnel in contamination control and sterilization requirements and procedures

Collaborates with Subject Matter Experts from other departments (i.e. Design Quality Engineering) to ensure a comprehensive approach to bring new and changed product into production

Assists sites as an expert consultant in sterile release, bioburden and dose audit, and environmental monitoring programs as necessary

Creates and finalizes validation protocols and report ensuring they are clear, concise and compliant to work instructions and standards

Knows and follows all laws and policies that apply to the position, and maintains the highest level of professionalism, ethics and compliance always

Participate in audits and other compliance program-related activities

Executes other duties/responsibilities as assigned by manager

Qualification

Sterilization expertiseFDAISO standardsContamination controlGap analysisValidation protocolsTraining skillsCompliance knowledgeCollaboration

Required