ETO Facility System Operator

Purpose:

The ETO Facility System Operator plays a critical role in managing and overseeing the operation of Ethylene Oxide (ETO) sterilization systems within a manufacturing or healthcare facility. This position ensures that sterilization processes are conducted safely, efficiently, and in compliance with all regulatory standards to maintain product integrity and safety. The operator is responsible for monitoring system performance, troubleshooting operational issues, and maintaining detailed records of sterilization cycles. Collaboration with maintenance, quality assurance, and production teams is essential to optimize system functionality and address any deviations promptly. Ultimately, the role contributes to the facility’s ability to deliver sterile products that meet stringent quality and safety requirements.

Essential Duties and Responsibilities

Sterilization Process Operation:

• Operate ETO sterilization equipment according to standard operating procedures (SOPs).
• Set up sterilization cycles in the system.
• Monitor sterilization parameters such as gas concentration, pressure, temperature, and humidity during sterilization cycles.

Equipment Monitoring and Maintenance:

• Schedule equipment maintenance in the system and communicate with the maintenance team to minimize downtime and ensure continuous operation.
• Perform routine verification for daily, weekly, monthly, quarterly, and annual maintenance.
• Checks and monitoring of ETO sterilization equipment to ensure proper function and prevent breakdowns.
• Report any equipment malfunctions or issues to the maintenance team for immediate repair.
• Control and monitor spare parts inventory.

Safety and Environmental Compliance:

• Follow all safety protocols for working with Ethylene Oxide, a hazardous substance, including the use of personal protective equipment (PPE).
• Ensure the proper handling and ventilation of ETO gas to protect personnel and the environment.
• Follow emergency response procedures for any incidents involving ETO gas leaks or safety concerns.

Documentation and Record-Keeping:

• Accurately complete sterilization DHR records, equipment logs, and other required documentation.
• Maintain clear and accurate records of cycle parameters, ensuring that all documentation meets FDA, ISO, and internal quality standards.
• Prepare and submit the sterilization DHR to QA for final approval.

Sterilization Cycle Monitoring:

• Continuously monitor sterilization cycles for proper operation, including gas injection, dwell times, and aeration phases.
• Identify and respond to any alarms or deviations during the sterilization cycle.

Troubleshooting and Problem Solving:

• Identify issues in the sterilization process or equipment, and take immediate action to troubleshoot problems.
• Work with the maintenance and engineering teams to resolve any technical issues or equipment failures.

Product Handling and Loading:

• Work with Material Handler to prepare products for sterilization, ensuring that they are properly loaded and spaced to allow for effective ETO penetration.
• Load and unload PCDs during the routine process.

Communication and Team Collaboration:

• Communicate with the QA team regarding sterilization process data, non-conformances, and any issues affecting product quality.
• Collaborate with cross-functional teams, including QA, maintenance, and production, to ensure smooth facility operations.

Education & Qualifications

• 1-3 years of experience operating industrial machinery or systems, preferably in sterilization or a related field.
• Experience with ETO sterilization processes is a plus but not required (on-the-job training may be provided).
• Knowledge of QMS, Good Manufacturing Practices (GMP), and CAPA systems.
• Strong mechanical aptitude and the ability to operate complex machinery.
• Excellent problem-solving skills.
• Strong communication and interpersonal skills.
• Attention to detail and a commitment to accuracy.
• Ability to work independently and troubleshoot equipment issues as they arise.
• Basic computer skills for data entry and documentation.

Physical Demands

• This position may require long periods of sitting or standing.
• Required to lift objective to 40lbs.
• Use of fingers, hands, or feel objects.
• Climb stairs.
• Stand, sit, stoop, kneel, and crouch.
• Close vision and depth perception.