Cleaning & Sterilization Technician - 2nd shift

About the role

This position ensures processing areas, equipment, tools, and controlled environments are maintained in accordance with current Good Manufacturing Practices (cGMP), standard operating procedures (SOPs), and applicable regulatory requirements. The technician plays a critical role in contamination control and facility readiness by executing cleaning schedules, preparing equipment for production use, maintaining accurate documentation, and supporting environmental and quality standards necessary for safe and effective processing operations.

Responsibilities

• Execute cleaning and disinfection procedures according to approved SOPs and work instructions
• Ensure proper cleaning, handling, and storage of processing tools
• Perform sterilization activities for reusable equipment, instruments, supplies, and manufacturing components
• Operate sterilization equipment and supporting systems in accordance with validated procedures
• Prepare items for sterilization, including inspection, packaging, labeling, and documentation
• Verify sterilization cycle parameters and ensure completion of required records
• Segregate sterile and non-sterile materials to prevent cross-contamination
• Maintain compliance with cGMP, FDA regulations, quality system requirements, and company procedures
• Report deviations, equipment issues, nonconformances, and safety concerns promptly
• Participate in audits, inspections, investigations, and continuous improvement activities as assigned
• Complete operational PMs of both Washers and Sterilizers

Requirements

• High school diploma or GED required
• CRCST, CSPDT, or equivalent sterile processing certification preferred
• Associate degree in a scientific, technical, or healthcare-related discipline preferred
• High attention to detail and organizational discipline
• Knowledge of GMP, FDA, or ISO standards is a plus
• 0–3 years of experience in a GMP manufacturing, cleanroom, pharmaceutical, biotechnology, tissue processing, medical device, healthcare, or sterile processing environment preferred
• Experience with inventory control, material allocation, and contamination control programs strongly preferred
• Experience with cleaning validation, contamination control, or sterilization processes is highly desirable
• Hands-on experience with process equipment scheduling in upstream/downstream bioprocessing

Working & Environmental Conditions

• Subject to handle potential infectious human tissue, nerves, umbilical cords, blood and bodily fluids
• Subject to handle chemicals and hazardous/non-hazardous waste
• Work involves risks or discomforts requiring proper standard and universal precautions in a biomedical manufacturing environment
• Use of PPE during various tasks/activities including gowns, gloves, masks, and safety glasses
• Potential exposure to latex from gloves
• May be required to sit for 2–4 hours or more debriding and evaluating unprocessed and processed human tissue
• Required to wear surgical magnification loupes for 2–4 hours or more to evaluate tissue