Cleaning & Sterilization Technician - 3rd shift

About the role

The Cleaning & Sterilization Technician performs cleaning, disinfection, sanitization, and sterilization activities that support tissue processing operations at the Axogen Processing Center (APC). This role 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.

Why you’ll love working at Axogen: friendly, open, and fun team culture that values unique perspectives; company‑wide dedication to profoundly impacting patients’ lives; comprehensive, high‑quality benefits package effective on date of hire; educational assistance available for all employees; matching 401(k) retirement plan; paid holidays, including floating holidays, to be used at your discretion; employee stock purchase plan; referral incentive program.

Mission and business purpose: Axogen’s purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. The company aims to lead the markets it serves by always requiring solutions that provide an improved benefit‑to‑risk profile compared with existing standards of care, guiding market and design requirement specifications for engineering, business development, and clinical research activities to objectively target advancements in standards of care.

Location: 913 Industrial Drive Place, Vandalia, OH 45377.

Working & environmental conditions: subject to handle potential infectious human tissue, nerves, umbilical cords, blood and bodily fluids; also 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 (e.g., use of safe workplace practices, wearing PPE such as gowns, gloves, masks, 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.

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

• 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 highly desirable
• Hands‑on experience with process equipment scheduling in upstream/downstream bioprocessing

Qualifications

• 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

Skills

• High attention to detail and organizational discipline
• Knowledge of GMP, FDA, or ISO standards (a plus)

Benefits

• Health, dental, and vision insurance
• Matching 401(k) retirement plan
• Paid Time Off
• 9 paid holidays + 3 floating holidays
• Dependent care flexible spending accounts
• Medical flexible spending accounts
• Tuition reimbursement
• Paid parental leave
• Paid caregiver leave
• Basic life insurance
• Supplemental life insurance
• Employee stock purchase plan
• Disability insurance

Pay

Hourly pay range: $21–$21 USD. 2nd shift eligible for an additional