Sterilization & Cleanroom Tech — Impactful Biotech Role

Axogen, Inc.; Vandalia (OH); On-site; USD 24,000 - 34,000; Full time

Benefits offered by this job

Annual bonus

Shift differential

Health benefits

Dental benefits

Vision benefits

Matching 401K

Paid time off

Floating holidays

Tuition reimbursement

Parental leave

Life insurance

Stock Purchase Plan

Disability insurance

Job summary

Axogen, Inc. in Vandalia, OH, is seeking a Cleaning & Sterilization Technician to support tissue processing operations at the APC. You will perform cleaning, disinfection, and sterilization to maintain compliant processing areas and equipment under cGMP and SOPs.

The role requires a high school diploma or GED, preferred CRCST/CSPDT, and up to 3 years in GMP sterile settings. Attention to detail and knowledge of GMP/FDA/ISO standards are valued as you help ensure safe, effective processing.

Qualifications

• High school diploma or GED required.
• CRCST, CSPDT, or equivalent certification preferred.
• Associate degree in a scientific/technical discipline preferred.
• High attention to detail and organizational discipline.
• GMP/FDA/ISO knowledge is a plus.
• 0–3 years in GMP manufacturing or sterile processing preferred.
• Experience with inventory control, contamination control programs preferred.
• Experience with cleaning validation or sterilization processes desirable.
• Hands-on equipment scheduling in upstream/downstream bioprocessing.

Responsibilities

• Execute cleaning and disinfection procedures per SOPs.
• Ensure proper handling and storage of processing tools.
• Perform sterilization activities for reusable equipment and components.
• Operate sterilization equipment per validated procedures.
• Prepare items for sterilization with inspection, packaging, labeling, and documentation.
• Verify cycle parameters and complete required records.
• Segregate sterile and non-sterile materials to prevent cross-contamination.
• Maintain compliance with cGMP, FDA, quality systems, and procedures.
• Report deviations, issues, and safety concerns promptly.
• Participate in audits, investigations, and continuous improvement.
• Complete operational PMs of washers and sterilizers.

Skills

Attention to detail

Organizational skills

GMP/FDA/ISO knowledge

Inventory control experience

Sterile processing experience

Education

High school diploma or GED

CRCST/CSPDT certification preferred

Associate degree preferred

Tools

Sterilization equipment

Documentation systems (SOPs)

Job description

Axogen, Inc. in Vandalia, OH, is seeking a Cleaning & Sterilization Technician to support tissue processing operations at the APC. You will perform cleaning, disinfection, and sterilization to maintain compliant processing areas and equipment under cGMP and SOPs.

The role requires a high school diploma or GED, preferred CRCST/CSPDT, and up to 3 years in GMP sterile settings. Attention to detail and knowledge of GMP/FDA/ISO standards are valued as you help ensure safe, effective processing.