Sterilization Technician
About The Position
The Sterilization Technician is a member of Life Science Outsourcing’s Sterilization Validation Services team, responsible for day-to-day steam and ethylene oxide (EtO) sterilization processing of customer medical devices and support for validation work. The role partners with Quality and the SVS Supervisor to process orders accurately and on time, follow established protocols, maintain complete records, and help ensure medical devices are safe for patient use. The position involves hands-on use and care of sterilization equipment, sensors, and testing materials in a regulated medical device environment. Work is performed on-site at the company’s Brea, California facility, operating under FDA 21 CFR Part 820 and ISO 13485 requirements.
Requirements
- High school diploma, or a combination of education and work experience that meets the role’s qualifications.
- Training in Good Laboratory Practices (GLP) and a basic understanding of aseptic techniques.
- A proven record of successfully completing assigned tasks.
- Effective written and verbal communication skills and good people skills.
- Ability to stay focused and produce error-free results.
- Ability to work independently with minimal supervision and take ownership of outcomes.
- Willingness to raise issues, procedural deviations, or improvement opportunities promptly.
- Ability to sit or stand for extended periods.
- Ability to repeatedly walk up and down stairs and walk extended distances as needed.
- Ability to assemble and organize orders weighing up to 50 pounds using appropriate equipment and tools.
Responsibilities
- Perform steam and EtO sterilization procedures for customer products according to prescribed protocols and manufacturing procedures.
- Read and follow protocols and LSO procedure documents.
- Review sterilization cycle records to confirm they meet acceptance criteria.
- Assemble and organize orders for processing and manage incoming and outgoing shipments.
- Perform Biological Indicator (BI) testing and initiate documentation for daily observation.
- Calibrate sensors and probes before and after sterilization.
- Wire steam sterilizers before validation when needed; retrieve, analyze, and finalize wire, sensor, and probe data.
- Assist with other validation-related duties as required.
- Accurately and legibly complete cycle records, process forms, and test data sheets.
- Complete monthly charts for the Quality department.
- Perform periodic preventive maintenance and EtO testing.
- Perform routine sterilizer upkeep, including refilling printer paper and verifying the DI water supply for EtO sterilizers.
- Coordinate with Quality and the supervisor to ensure order accuracy and timely completion.
- Keep Quality and cross-functional partners aligned on order requirements and validation timelines.
- Inform the SVS Supervisor about order progress, issues, procedural deviations, and improvement opportunities.
- Take on other duties as assigned by the SVS Supervisor.
Benefits
- Hands-on experience with steam and EtO sterilization.
- Regulated-industry experience in an FDA-registered, ISO 13485-certified company.
- Collaborative team environment where contributions are visible and valued.
- Opportunity to grow technical and validation expertise.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
