Sterilization Technician
LIFE SCIENCE OUTSOURCING INC
Summary
Run the Sterilization Processes That Make Medical Devices Safe for Patients. At Life Science Outsourcing (LSO), we help bring life-saving and life-improving medical devices to the patients who need them. Our Sterilization Validation Services (SVS) team runs in-house steam and ethylene oxide (EtO) sterilization for medical device companies across the industry. As a Sterilization Technician, you'll process customer products through those cycles and support the validations that prove they work.
Job description
What You'll Do
As a key member of our SVS team, you'll own day-to-day sterilization processing and support validation work, partnering closely with Quality and your supervisor to deliver accurate orders on time.
Sterilization Processing
- Perform steam and EtO sterilization procedures for customer products according to prescribed protocols and manufacturing procedures.
- Read and correctly follow protocols and LSO procedure documents.
- Check each sterilization cycle record to confirm it meets acceptance criteria.
- Assemble and organize orders for processing and manage incoming and outgoing shipments.
Testing & Validation Support
- Perform Biological Indicator (BI) testing and initiate testing documentation for daily observation.
- Calibrate sensors and probes before and after sterilization.
- Wire steam sterilizers prior to validation when needed, then retrieve, analyze, and finalize wire, sensor, and probe data.
- Assist with other validation-related duties as required.
Documentation & Quality Records
- Accurately and legibly complete cycle records, process forms, and test data sheets.
- Complete monthly charts for the Quality department.
Equipment Care & Maintenance
- Complete periodic preventive maintenance (PM) and EO testing.
- Perform routine sterilizer upkeep, such as refilling printer paper and verifying the DI water supply for EtO sterilizers, to keep operations running without interruption.
Communication & Teamwork
- Work directly with Quality and your supervisor to ensure order accuracy and timely completion.
- Keep Quality and cross-functional partners aligned on order requirements and validation timelines.
- Keep the SVS Supervisor informed on order progress, issues, procedural deviations, and improvement opportunities.
- Take on other duties as assigned by the SVS Supervisor.
Qualifications: What You Bring
Skills & Experience
- High school diploma, or a combination of education and work experience that meets the qualifications of the role.
- 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 and good people skills.
Mindset & Impact
- You stay focused on the task in front of you and produce error-free results.
- You work independently with minimal supervision and own your outcomes.
- You speak up early about issues, deviations, or better ways of doing things.
- You understand that every record you complete supports patient safety.
Work Environment
- On-site at our Brea, CA facility.
- Regulated medical device environment operating under FDA 21 CFR Part 820 and ISO 13485.
- Hands-on work with steam and ethylene oxide (EtO) sterilizers, following established procedures.
- Must be able to sit or stand for extended periods of time.
- Must be able to walk up and down stairs repeatedly and walk extended distances as needed.
- Must be able to assemble and organize orders of up to 50 lbs for sterilization processing, using appropriate equipment and tools.
Requirements
- High school diploma, or a combination of education and work experience that meets the qualifications of the role
- Training in Good Laboratory Practices (GLP)
- Basic understanding of aseptic techniques
- A proven record of successfully completing assigned tasks
- Effective written and verbal communication and good people skills
- Ability to work independently with minimal supervision
- Strong attention to detail and error-free results
- Ability to sit or stand for extended periods
- Ability to walk up and down stairs repeatedly and walk extended distances
- Ability to assemble and organize orders of up to 50 lbs
Benefits
- Mission-driven work
- Hands-on sterilization experience
- FDA-registered, ISO 13485-certified environment
- Collaborative team
- Growth opportunities
Company overview
Life Science Outsourcing, Inc. (LSO) is a performance-driven Contract Manufacturing Organization (CMO/CDMO) specializing in medical device manufacturing services. Founded in 1997 and headquartered in Brea, California, the company operates FDA-registered and ISO 13485-certified facilities across the United States and Costa Rica, spanning over 125,000 square feet. LSO provides comprehensive end-to-end solutions including medical device assembly, packaging, sterilization, medical package testing, reagent packaging and design, thermoforming, and resorbables manufacturing. The company serves diverse MedTech markets including orthopedics, cardiovascular devices, neuromodulation, diagnostics, and minimally invasive devices. With a team of 51-200 employees, LSO leverages deep regulatory expertise to help medical device innovators accelerate their go-to-market launches while streamlining supply chains and mitigating risks. Their unique business model combines in-house capabilities with extensive quality management systems, offering 12 cleanrooms ranging from Class 5 to 8 and specialized manufacturing environments for bioabsorbable polymers.