Summary

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.

Job description

Job Summary

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.

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

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.

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

Benefits

Health Insurance
Dental Insurance
Vision Insurance
Matching 401(k)
Paid Time Off
9 Paid Holidays
3 Floating Holidays
Dependent Care FSA
Medical FSA
Tuition Reimbursement
Paid Parental Leave
Paid Caregiver Leave
Basic Life Insurance
Supplemental Life Insurance
Employee Stock Purchase Plan
Disability Insurance
Annual Performance Bonus
Shift Differential

Company overview

Axogen, Inc. (NASDAQ: AXGN) is a leading medical device company exclusively focused on the science, development, and commercialization of innovative technologies for peripheral nerve regeneration and repair. As the only company solely dedicated to peripheral nerve repair, Axogen has pioneered a comprehensive portfolio of clinically proven solutions that address various types of nerve injuries. The company's flagship product, Avance Nerve Graft, is a biologically active processed human nerve allograft designed for bridging severed peripheral nerves without requiring a second surgical site. Axogen's product line also includes the Axoguard family of products - Nerve Connector, Nerve Protector, and Nerve Cap - which utilize porcine extracellular matrix technology to protect and repair damaged nerves. With operations in the United States, Canada, Germany, the United Kingdom, Spain, South Korea, and other countries, Axogen is committed to restoring nerve function and improving quality of life for patients suffering from peripheral nerve injuries through innovative, clinically validated, and economically effective surgical solutions.