Maintenance Technician

Keep the Equipment Running That Builds Life-Saving Medical Devices

At Life Science Outsourcing (LSO), the devices our teams build end up in operating rooms and hospitals where they help real patients. None of that happens without equipment that runs reliably. As a Maintenance Technician at our Brea, California cleanroom manufacturing site, you keep that equipment, our HVAC and HEPA filtration systems, and our facility infrastructure performing safely and in full compliance with FDA and ISO 13485 requirements.

This role is a fit if you like solving mechanical and electrical problems with your hands, take pride in clean documentation, and want your work to matter beyond the shop floor. You will move between PM work orders, troubleshooting calls, and facility projects, and you will see the direct line between what you fix and what we ship.

What You'll Do

Working within an FDA-regulated, ISO 13485-certified environment, you will own the preventive and corrective maintenance that keeps production and the building moving.

Preventive Maintenance

• Execute scheduled PM tasks on cleanroom production equipment, HVAC/HEPA filtration, compressed air systems, and utilities, following written SOPs and PM work orders.
• Document all PM activity in the eQMS, recording findings, parts used, and corrective actions.
• Monitor and record cleanroom environmental parameters (temperature, humidity, differential pressure) and escalate deviations per procedure.
• Inspect and replace HEPA filters, pre-filters, and related air-handling components on validated schedules.

Corrective Maintenance and Troubleshooting

• Diagnose and repair mechanical, electrical, and equipment failures with minimal downtime to production.
• Troubleshoot PLCs, motor controls, conveyors, sealing equipment, and general manufacturing machinery.
• Escalate complex failures to senior maintenance staff or outside vendors, with accurate fault and repair documentation.
• Respond to emergency maintenance requests during and outside scheduled shift hours as business needs require.

Facility and Infrastructure Support

• Perform general facility work including plumbing, painting, carpentry, lighting, and interior repairs.
• Support calibration activities by coordinating with Quality and external calibration vendors so equipment stays tracked and available.
• Assist with installation and qualification of new equipment, including IQ/OQ/PQ protocols as directed.
• Maintain proper storage and security of tools, spare parts, and hazardous materials per SDS and site safety policy.

Cleanroom and Quality Compliance

• Follow all cleanroom gowning, behavior, and contamination-control protocols in ISO-classified areas.
• Ensure maintenance activities comply with cGMPs, FDA 21 CFR Part 820, and ISO 13485 requirements.
• Participate in non-conformance investigations, CAPA processes, and internal or external audits as requested.
• Complete work orders, maintenance logs, and deviation reports accurately to support traceability and audit readiness.

Safety

• Adhere to all Cal/OSHA Title 8 regulations and LSO safety policies, including lockout/tagout, arc flash, confined space, and chemical safety.
• Promptly report unsafe conditions, near-misses, and injuries, and participate in safety investigations.
• Maintain current training certifications for all assigned safety programs.

What You Bring

Skills & Experience

• High school diploma or GED required. A technical or vocational degree or certificate in industrial maintenance, mechatronics, HVAC, or a related field is preferred.
• Minimum 3 years of hands-on maintenance experience in a manufacturing environment. Medical device, pharmaceutical, or other FDA-regulated experience is strongly preferred.
• Demonstrated experience with preventive maintenance programs and CMMS software.
• Practical knowledge of HVAC/HEPA filtration, pneumatics, and electrical and mechanical troubleshooting.
• Ability to read and interpret technical manuals, P&IDs, electrical schematics, and maintenance procedures.
• Working knowledge of Cal/OSHA regulations, LOTO procedures, and safe chemical handling.

Mindset & Impact

• Strong attention to detail and a real commitment to accurate documentation.
• Comfortable working independently and juggling multiple open work orders with shifting priorities.
• A collaborator who interacts professionally with Quality, Production, and Operations.
• Familiar with how cGMP and ISO 13485 principles apply to maintenance work, or eager to learn them.

Nice to Have

• Cleanroom maintenance experience in ISO Class 7 or 8 environments.
• Calibration coordination experience in a regulated manufacturing setting.
• Certifications in electrical, HVAC, or industrial maintenance.

Why Join LSO?

• Your work directly supports the manufacture of life-saving medical devices.
• Hands-on variety: production equipment, building systems, and facility projects, not the same task every day.
• Regulated-industry experience (FDA, ISO 13485) that strengthens your career.
• A team that treats safety, quality, and precision as non-negotiable standards.

Work Environment

• On-site at our Brea, CA manufacturing facility.
• Ability to lift and carry up to 50 pounds.
• Regular standing, walking, bending, stooping, kneeling, and reaching.
• Work performed in office and break areas and on the production and facilities floor, including cleanroom environments requiring full gowning.
• Exposure to chemicals, solvents, compressed air, and mechanical hazards. Appropriate PPE is provided and required.
• Occasional off-shift, weekend, or emergency response work may be required.

Make an Impact

Every filter you replace, every machine you bring back online, and every clean record you log keeps our cleanroom producing the devices clinicians depend on. This is maintenance work where reliability is measured in patient outcomes, not just uptime. If that is the kind of impact you want from a hands-on technical role, we would like to meet you.

Life Science Outsourcing, Inc. • Brea, CA