Cleaning & Sterilization Technician - 2nd shift
About The Position
The Cleaning & Sterilization Technician is responsible for performing cleaning, disinfection, sanitization, and sterilization activities that support tissue processing operations at the Axogen Processing Center (APC). This position ensures processing areas, equipment, tools, and controlled environments are maintained in accordance with current Good Manufacturing Practices (cGMP), standard operating procedures (SOPs), and applicable regulatory requirements. The technician plays a critical role in contamination control and facility readiness by executing cleaning schedules, preparing equipment for production use, maintaining accurate documentation, and supporting environmental and quality standards necessary for safe and effective processing operations.
Requirements
- High school diploma or GED required.
- High attention to detail and organizational discipline
- 0-3 years of experience in a GMP manufacturing, cleanroom, pharmaceutical, biotechnology, tissue processing, medical device, healthcare, or sterile processing environment preferred.
Nice To Haves
- CRCST, CSPDT, or equivalent sterile processing certification preferred.
- Associate degree in a scientific, technical, or healthcare-related discipline preferred.
- Knowledge of GMP, FDA, or ISO standards is a plus
- 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.
Benefits
- Comprehensive, high-quality benefits package effective on date of hire
- Educational assistance available for all employees
- Matching 401(k) retirement plan
- Paid holidays, including floating holidays, to be used at your discretion
- Employee Stock Purchase Plan
- Referral incentive program
- Annual performance bonus after 6 months of service.
- Additional shift differential for 2nd shift ($1.50/hr).
- Health, Dental, Vision
- Dependent Care Flexible Spending Accounts
- Medical Flexible Spending Accounts
- Tuition Reimbursement
- Paid Parental Leave
- Paid Caregiver Leave
- Basic Life Insurance
- Supplemental Life Insurance
- Disability Insurance
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
