Sterilization Tech: Cleanroom GMP Specialist, Day 1 Benefits

axogen; Vandalia (OH); On-site; USD 42,000 - 64,000; Full time

Benefits offered by this job

Benefits on day one

Educational assistance

Matching 401(k) plan

Paid holidays (floating)

Employee Stock Purchase Plan

Referral incentive program

Job summary

Axogen is seeking a Cleaning & Sterilization Technician to support tissue processing at the Axogen Processing Center (APC). You will perform cleaning, disinfection, sanitization, and sterilization according to cGMP and SOPs to keep equipment and environments compliant.

The role requires a high school diploma or GED, sterile processing certification preferred, and attention to detail. Experience in GMP environments, documentation, inventory control, and operating sterilization equipment is valued.

Qualifications

• High school diploma or GED required.
• CRCST, CSPDT, or equivalent certification preferred.
• Associate degree in a scientific/technical/healthcare field preferred.
• Strong attention to detail and organizational discipline.
• Knowledge of GMP, FDA, or ISO standards is a plus.
• 0-3 years in GMP manufacturing or sterile processing preferred.
• Experience with cleaning validation or contamination control is desirable.
• Hands-on scheduling experience with processing equipment is a plus.

Responsibilities

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

Skills

Attention to detail

GMP knowledge

Sterile processing

Documentation

Inventory control

Safety awareness

Education

High school diploma or GED

CRCST or CSPDT certification preferred

Associate degree preferred

Job description

Axogen is seeking a Cleaning & Sterilization Technician to support tissue processing at the Axogen Processing Center (APC). You will perform cleaning, disinfection, sanitization, and sterilization according to cGMP and SOPs to keep equipment and environments compliant.

The role requires a high school diploma or GED, sterile processing certification preferred, and attention to detail. Experience in GMP environments, documentation, inventory control, and operating sterilization equipment is valued.