Sterilization Specialist

The Sterilization Specialist supports all sterilization and microbiological methods and processes related to ROi CPS, LLC custom procedure tray manufacturing operations. This position works closely with all departments within ROi CPS, LLC and provides technical assistance to Quality Assurance, Process Engineering and Production personnel concerning sterilization and microbiological issues.  The Sterilization Specialist is responsible for sterilization cycle development, process validations related to sterilization, equivalency reviews, evaluating new or revised components and products for impact on sterilization, investigating alternate sterilization facilities and methods, and providing input to create strategies to assure compliance with regulatory standards regarding sterilization of ROi CPS, LLC products.

• Manage ROi CPS product sterilization program to ensure sterility assurance levels are maintained for patient safety.
• Prepare and execute sterilization validation protocols and compile reports to ensure the appropriate regulatory requirements are met and sterility assurance levels are maintained. Prepare test products as needed for validations. Coordinate with 3rd party testing laboratories to ensure appropriate testing methods are defined and utilized.
• Evaluate the impact of existing sterilization methods on new or modified components and finished products. Develop and implement sterilization adoption studies and comparative resistance studies as needed.
• Evaluate the impact of new or modified manufacturing processes on existing sterilization methods and validations.
• Prepare, execute and maintain process validations that have an impact on sterility assurance levels.
• Investigate sterilization deviations and determine appropriate corrective actions with contract sterilizers.
• Participate in contract sterilizer supplier audits as Subject Matter Expert (SME) and assist with qualification of new contract sterilizers.
• Monitor applicable regulatory requirements and guidance and provide input to creating strategies to ensure compliance.
• Provide guidance and methodologies for bioburden monitoring, environmental monitoring and clean room practices. Ensure company documentation related to sterilization and microbiological controls are maintained and updated for compliance with current regulations, standards and industry best practices.
• Assist with training and orientation of other colleagues, as needed.

Education & Experience:

• Bachelor's degree in Microbiology, Biological Sciences or Engineering Required
• 3+ years of experience in sterilization/microbiology in the medical device industry to include Ethylene Oxide and Gamma or X-ray sterilization Required

HealthTrust Supply Chain is a critical part of HCA Healthcare’s strategy. Our focus is to improve performance and reduce costs. We do this by joining non-clinical and administrative functions. HealthTrust Supply Chain best practice methodologies. We develop, apply and monitor cost-efficient initiatives and programs for HCA Healthcare. By improving facility efficiency, medical professionals can focus on our mission - patient care.