Cleaning & Sterilization Technician - 3rd shift

Axogen, Inc.; Vandalia (OH); On-site; USD 25,000 - 33,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Matching 401K

Paid time off

9 holidays + 3 floating holidays

Job summary

Axogen is seeking a Cleaning & Sterilization Technician in Vandalia, OH to perform cleaning, disinfection, sanitization, and sterilization for the Axogen Processing Center. You will help maintain compliant environments and accurate documentation under cGMP and SOPs.

Qualifications include a high school diploma or GED, and preferred CRCST/CSPDT certification or an associated technical degree. Experience with GMP/ISO standards and sterile processing is a plus. Competitive benefits apply.

Qualifications

• High school diploma or GED is required.
• CRCST, CSPDT, or equivalent certification preferred.
• Associate degree in a scientific, technical, or healthcare-related discipline preferred.
• Knowledge of GMP, FDA, or ISO standards is a plus.

Responsibilities

• Execute cleaning and disinfection procedures according to SOPs.
• Ensure proper cleaning, handling, and storage of processing tools.
• Perform sterilization activities for reusable equipment and components.
• Operate sterilization equipment per validated procedures.
• Prepare items for sterilization including packaging and labeling.
• Verify sterilization cycle parameters and maintain records.
• Maintain separation of sterile and non-sterile materials to prevent cross-contamination.
• Comply with cGMP, FDA regulations, and company procedures.
• Report deviations or safety concerns promptly.
• Participate in audits and continuous improvement activities.
• Complete PMs of Washers and Sterilizers.

Skills

Attention to detail

GMP/FDA/ISO knowledge

Sterile environment familiarity

Education

High school diploma or GED

CRCST/CSPDT certification preferred

Associate degree preferred

Tools

Sterile processing equipment

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

• 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 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 unprocessed and processed tissue.

Location 913 Industrial Drive Place, Vandalia, OH 45377 #zr

Benefits/Compensation

This position is eligible for an annual performance bonus after 6 months of service. 2nd and 3rd shift positions are eligible for additional shift differential. 2nd shift is an additional $1.50/hr and 3rd shift is an additional $2.00/hr.

• Health
• Dental
• Vision
• Matching 401K
• 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, as described in more detail in summary plan descriptions.

Hourly Pay Range

$21 - $21 USD

Company Statements

Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion. As AI is becoming a common tool throughout the application process, we want to be clear about its appropriate use at Axogen. Using AI to support resume writing, research or interview preparation is perfectly acceptable, provided the content is accurate and genuinely represents your qualifications and skills. For other key parts of your interview process, however, it is important that the ideas, communication, and work you share reflect your own voice, experiences, and thinking. We ask that you participate in our live interviews and complete any assessments without AI assistance unless instructions explicitly indicate otherwise or a specific exception is discussed and approved in advance. This approach ensures fairness, celebrates your individuality, and allows your authentic perspective to shine. Behaviors that do not align with these guidelines may result in disqualification from the hiring process or termination of employment if later discovered. We appreciate your understanding and look forward to learning about the unique contributions only you can bring to Axogen.