Support multiple quality assurance projects and activities to meet the sterilization validation requirements of medical products. Lead sterilization process commissioning, initial sterilization validation and re-validation activities. Provide technical support for sterilization and environmental control activities. Job duties:

• Conduct revalidations for steam, Ethylene Oxide, and radiation sterilization processes. Work closely with Operations and Quality Engineering teams to coordinate and execute revalidation activities.
• Conduct technical justifications and physical studies for adoption of new products into existing sterilization cycles, including, but not limited to, sterilization validation, endotoxin level testing (LAL), product bioburden testing, and residual testing.
• Generate project plans, validation master plans, test protocols, and reports for sterilization validation.
• Coordinate microbiological testing of validation samples with in-house and outside laboratories.
• Work with new product development teams on establishing sterilization strategies for steam, radiation, and ethylene oxide sterilization.
• Support cycle development activities for sterilization processes, including, but not limited to:
• Determine loading configurations. Determine sterilization cycle parameters based on fractional cycle approach. Identify appropriate PCD configurations, resistance hierarchy, and required quantity for validation.
• Provide sterilization expertise during interface with regulatory agencies, including FDA and ISO.
• Support clean room monitoring and validation activities, including, but not limited to, microbial, particulate, and pressure differential testing.
• Manage sample inventories for real time and accelerated aging studies to support Design Quality/R&D projects.
• Provide expertise and write-ups to support NCRs and/or CAPAs.
• Perform other duties as assigned.

• Conduct revalidations for steam, Ethylene Oxide, and radiation sterilization processes. Work closely with Operations and Quality Engineering teams to coordinate and execute revalidation activities.
• Conduct technical justifications and physical studies for adoption of new products into existing sterilization cycles, including, but not limited to, sterilization validation, endotoxin level testing (LAL), product bioburden testing, and residual testing.
• Generate project plans, validation master plans, test protocols, and reports for sterilization validation.
• Coordinate microbiological testing of validation samples with in-house and outside laboratories.
• Work with new product development teams on establishing sterilization strategies for steam, radiation, and ethylene oxide sterilization.
• Support cycle development activities for sterilization processes, including, but not limited to:
• Determine loading configurations. Determine sterilization cycle parameters based on fractional cycle approach. Identify appropriate PCD configurations, resistance hierarchy, and required quantity for validation.
• Provide sterilization expertise during interface with regulatory agencies, including FDA and ISO.
• Support clean room monitoring and validation activities, including, but not limited to, microbial, particulate, and pressure differential testing.
• Manage sample inventories for real time and accelerated aging studies to support Design Quality/R&D projects.
• Provide expertise and write-ups to support NCRs and/or CAPAs.
• Perform other duties as assigned