Sterilization & Cleanroom Technician — Day-One Benefits

axogen; Vandalia (OH); On-site; USD 42,000 - 62,000; Full time

Benefits offered by this job

Benefits on day one

401(k) plan

Employee Stock Purchase Plan

Educational assistance

Paid holidays

Job summary

Axogen is seeking a Cleaning & Sterilization Technician to support the Axogen Processing Center. You will perform cleaning, disinfection, sanitization, and sterilization to maintain compliant processing environments and equipment.

Responsibilities include maintaining documentation, ensuring readiness for production, and adhering to cGMP, SOPs, and regulatory requirements. Prior experience in sterile processing is preferred, with high attention to detail.

Qualifications

• High school diploma or GED required.
• CRCST, CSPDT, or equivalent 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

• 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.

Skills

Attention to detail

Organizational skills

GMP knowledge

Safety compliance

Education

High school diploma or GED

Associate degree in a scientific/healthcare-related field

CRCST/CSPDT certification

Tools

Sterilization equipment operation

Inventory control systems

Job description

Axogen is seeking a Cleaning & Sterilization Technician to support the Axogen Processing Center. You will perform cleaning, disinfection, sanitization, and sterilization to maintain compliant processing environments and equipment.

Responsibilities include maintaining documentation, ensuring readiness for production, and adhering to cGMP, SOPs, and regulatory requirements. Prior experience in sterile processing is preferred, with high attention to detail.