Senior Sterility Scientist

• 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

• 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

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.

• Sterilization Compliance
• FDA Regulations
• ISO 13485
• Microbiology Standards
• Contamination Control

• Sterilization
• Microbiology
• Validation Protocols
• Standard Operating Procedures
• Gap Analysis
• Regulatory Compliance
• Contamination Control Measures
• Test Report Writing
• Manufacturing Experience
• ISO Documents Knowledge

• Training
• Guidance
• Problem Solving

• Medical Device
• Pharmaceutical
• Food Industry
• Canadian Medical Device Regulations
• European Medical Device Regulation

• Microsoft Office