GMP Cleanroom Sterilization Technician

Axogen, Inc.; Vandalia (OH); Sur place; USD 25 000 - 33 000; Plein temps

Avantages offerts par ce poste

Performance bonus after 6 months

Shift differential (2nd/3rd shifts)

Health, dental, vision

Matching 401K

Paid time off

9 holidays + 3 floating holidays

Tuition reimbursement

Employee stock purchase plan

Résumé du poste

Axogen, Inc. is seeking a Cleaning & Sterilization Technician in Vandalia, OH to perform cleaning, disinfection, sanitization, and sterilization for tissue processing at the APC. You will help maintain compliant facilities, equipment, and documentation to support safe, effective processing operations.

The role requires attention to detail, GMP knowledge, and experience in sterile processing. Benefits and a competitive hourly rate are included, with opportunities for shift differentials on

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, pharma, biotech, 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

Responsabilités

• 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.

Connaissances

Attention to detail

Organizational discipline

GMP/FDA/ISO knowledge

Inventory control

Contamination control

Sterilization processes

Process equipment scheduling

Formation

High school diploma or GED

CRCST/CSPDT certification

Associate degree in scientific/technical/healthcare

Outils

Sterilization equipment

Description du poste

Axogen, Inc. is seeking a Cleaning & Sterilization Technician in Vandalia, OH to perform cleaning, disinfection, sanitization, and sterilization for tissue processing at the APC. You will help maintain compliant facilities, equipment, and documentation to support safe, effective processing operations.

The role requires attention to detail, GMP knowledge, and experience in sterile processing. Benefits and a competitive hourly rate are included, with opportunities for shift differentials on