Cleaning & Sterilization Technician - 2nd shift

axogen; Vandalia (OH); On-site; USD 42,000 - 54,000; Full time

Benefits offered by this job

Benefits on day one

Educational assistance

401(k) matching

Employee Stock Purchase Plan

Paid holidays

Floating holidays

Referral incentive program

Job summary

Axogen is seeking a Cleaning & Sterilization Technician to support tissue processing at the Axogen Processing Center. You will perform cleaning, disinfection, sanitization and sterilization to uphold cGMP and SOP standards, ensuring equipment and environments meet regulatory requirements.

The role emphasizes contamination control, accurate documentation, and readiness for production. A high school diploma is required; CRCST/CSPDT certifications are a plus; associate degree preferred; 0–3 years

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.
• High attention to detail and organizational discipline
• Knowledge of GMP, FDA, or ISO standards is a plus
• 0-3 years of experience in 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

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.

Education

High school diploma or GED

Associate degree in a scientific, technical, or healthcare-related discipline

Tools

GMP knowledge

Job description

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!

Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.

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

Axogen Mission and Business Purpose

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.

Job Summary of the Cleaning & Sterilization Technician

The Cleaning & Sterilization Technician is responsible for performing cleaning, disinfection, sanitization, and sterilization activities that support tissue processing operations at the Axogen Processing Center (APC). 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.

Requirements of the Cleaning & Sterilization Technician

• 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

Responsibilities of the Cleaning & Sterilization Technician

The specific duties of the Cleaning & Sterilization Technician include but are not limited to:

• 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.

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 which require proper standard and universal precautions in a Biomedical manufacturing environment e.g., use of safe workplace practices with manufacturing equipment, wearing PPE during various tasks/activities including but not limited to, gowns, gloves, masks and safety glasses. Potential exposure to latex from gloves. May be required to sit for 2-4 ho