Sterization Process Operator

Job Summary

This role involves monitoring the sterilizer system by observing pressure, temperature, and relative humidity measurements on charts or computer monitors. The individual will ensure that products are moved through the facility at the appropriate times, safely handling them before and after the sterilization process. This includes maintaining product flow, documentation, and safety protocols in compliance with standard operating procedures (SOPs) and applicable standards (ISO 13485 and 21 CFR Part 820).

Responsibilities

• Monitor and operate sterilizer systems, ensuring correct cycle parameters are achieved and maintained throughout the cycle.
• Observe pressure, temperature, and relative humidity measurements on charts or computer monitors.
• Adjust controls, valves, and system settings in accordance with validated process specifications and SOPs.
• Perform pre-cycle setup and post-cycle unloading activities, including verifying product identification, load configuration, label creation, and palletization.
• Report any abnormal system performance or alarm conditions promptly to the Process Supervisor.
• Document all process readings and cycle data accurately in batch records, logbooks, or electronic data systems as needed, ensuring all processing documentation is complete, accurate, and compliant with company SOPs and applicable standards.
• Turn valves and adjust controls to ensure the safe operation of the equipment.
• Observe sterilizers and auxiliary units to detect malfunctions and assist with repairs as needed.
• Report system problems to the Engineering team and assist with troubleshooting, repairs, and requalification activities as needed.
• Perform daily and weekly equipment preventative maintenance tasks, assist Maintenance as required, and maintain cleanliness and orderliness of the sterilization and staging areas to support cGMP and safety requirements.
• Unload, package, and ship products.
• Report any damaged product to the Process Supervisor/Manager.
• Store and remove chemicals used in processing in accordance with established procedures and laws.
• Participate in plant safety committees and follow all established safety rules and regulations.
• Actively identify and propose enhancements to processes, systems, or procedures to drive continuous improvement.
• Assist with other tasks as assigned by Supervisor.

Skills & Qualifications

• High School Diploma or GED required; Associate degree in technology (mechanical, electrical, HVAC, etc.) preferred.
• Minimum of six (6) months to one (1) year of experience working in a sterilization/chemical environment preferred.
• Willing to work established shifts and overtime as needed.
• Proficient in basic arithmetic including addition, subtraction, multiplication, and division using whole numbers, fractions, and decimals.
• Forklift driving experience required.
• Fluent in reading, writing, and speaking English.
• Experience with mechanical devices, tools, and testing equipment required.
• Utilize technology (laptop and computer software such as Microsoft Office) to perform administrative duties as required.
• High level of professionalism with excellent interpersonal and customer service skills.
• Excellent time management skills, able to prioritize multiple tasks simultaneously.
• Ability to work in a fast-paced environment with flexibility to adjust to and meet changing priorities.
• Make good business judgments and decisions in relation to efficiency and effectiveness while meeting daily service expectations.
• Ability to evaluate situations, possess good problem-solving skills, and prioritize factors in decision making.
• Dependable and punctual.
• Maintains a positive attitude and a strong work ethic.
• Must be authorized to work in the United States.

Essential Functions/Physical Requirements

• Regularly lift and move up to 25 lbs.
• Frequently lift and move up to 50 lbs.
• Occasionally lift and move up to 100 lbs.
• Push/pull weights of 100 lbs.
• Frequently required to stand, walk, sit, use hands to handle and feel, use arms to reach, climb, balance, stoop, kneel, crouch, crawl, talk, and hear.
• Must be able to crouch, stoop, or squat to work inside or under equipment, or move through low headroom spaces.
• Able to occasionally work in tight spaces.

Location

Branchburg, NJ is a vibrant community known for its scenic landscapes and proximity to major metropolitan areas. It offers a welcoming environment for both residents and businesses, with a strong sense of community and excellent amenities.

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