Sterilization & Cleanroom Technician

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 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