Quality Engineer II - Sterilization

About the role

The Sterilization Quality Engineer II ensures the highest standards of sterility assurance and environmental monitoring across the organization. The role provides strategic oversight of sterilization processes, environmental monitoring systems, contamination control strategies and related quality system activities. Expertise in Ethylene Oxide (EO) and irradiation (Gamma and E-Beam) is highly desirable.

Key responsibilities

• Support and maintain Global Sterility Assurance and Contamination Control programs aligned with all manufacturing sites
• Provide quality oversight of sterilization processes (EO, Gamma, Electron Beam and others) and support their validation, requalification and change assessments
• Analyze sterilization data, dose audits, cycle performance and validation results
• Support contamination control strategy development and implementation, including media aseptic processing
• Support Environmental Monitoring programs (viable and non-viable), review trends and investigate excursions and action level events
• Partner with Microbiology and Operations to implement corrective actions, and support cleanroom qualification and performance monitoring
• Lead root cause investigations of contamination events, EM excursions, sterilization failures and process deviations using tools such as 5-Why, Fishbone and Fault Tree Analysis
• Develop and verify CAPAs

Required profile

• 3+ years of experience in medical device, pharmaceutical, biologics or healthcare
• Demonstrated experience with sterilization processes (EO, Gamma, Electron Beam, X-ray or equivalent) and their validations and lifecycle management
• Experience with Environmental Monitoring, cleanroom operations, contamination control or microbiological quality systems
• Experience with RCA, CAPA, nonconformance management, deviations and change control; audit and inspection experience preferred
• Bachelor's degree in health, engineering or science preferred; sterilization association certification, ASQ or other professional certification preferred

Required skills

• Knowledge of ISO 11135, ISO 11137, FDA 21 CFR Part 820, ISO 13485 and other regulatory requirements
• Understanding of sterility assurance, SAL, bioburden management and contamination prevention
• Proficiency in Microsoft Excel, Word, Outlook and PowerPoint
• Statistical analysis and trending of process and environmental data