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.

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 401k
Paid time off
Paid holidays
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.