Cleaning & Sterilization Technician - 2nd shift

Axogen, Inc.; Vandalia (OH); Sur place; USD 25 000 - 33 000; Plein temps

Avantages offerts par ce poste

Performance bonus after 6 months

Shift differential (2nd/3rd shifts)

Health, dental, vision

Matching 401K

Paid time off

9 holidays + 3 floating holidays

Tuition reimbursement

Employee stock purchase plan

Résumé du poste

Axogen, Inc. is seeking a Cleaning & Sterilization Technician in Vandalia, OH to perform cleaning, disinfection, sanitization, and sterilization for tissue processing at the APC. You will help maintain compliant facilities, equipment, and documentation to support safe, effective processing operations.

The role requires attention to detail, GMP knowledge, and experience in sterile processing. Benefits and a competitive hourly rate are included, with opportunities for shift differentials on

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, pharma, biotech, 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

Responsabilités

• 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.

Connaissances

Attention to detail

Organizational discipline

GMP/FDA/ISO knowledge

Inventory control

Contamination control

Sterilization processes

Process equipment scheduling

Formation

High school diploma or GED

CRCST/CSPDT certification

Associate degree in scientific/technical/healthcare

Outils

Sterilization equipment

Description du poste

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.
• Benefits offered for this position include 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, and 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.