Sr. Engineering Technician

Senior Engineering Technician (San Clemente, CA) Join a growing manufacturing team where you'll play a critical role in keeping production equipment running efficiently, compliantly, and safely within a regulated environment. As a Senior Engineering Technician, you'll provide hands-on technical support, troubleshoot equipment issues, support equipment qualifications and validations, and partner closely with Engineering, Quality, and Manufacturing teams to drive continuous improvement and minimize downtime.

Key Responsibilities

Provide technical support to manufacturing operations and ensure equipment readiness. Troubleshoot and resolve equipment and process-related issues on the production floor. Support calibration, maintenance, and preventive maintenance activities. Execute equipment qualifications (IQ/OQ/PQ) and validation protocols. Maintain accurate documentation and records in compliance with cGMP, GDP, and Quality System requirements.

Assist with investigations, nonconformances (NCs), and CAPA activities. Partner cross-functionally with Engineering, Quality, Manufacturing, Supply Chain, and R&D teams. Support operator training on equipment, processes, and procedures.

Qualifications

High School Diploma or GED required. Associate degree, technical certification, or equivalent combination of education and experience preferred. 6 to 8 years of experience supporting manufacturing operations in a regulated industry such as medical device, pharmaceutical, or biotechnology. At least 2 years of hands-on experience troubleshooting and supporting manufacturing equipment.

Experience executing equipment qualifications (IQ/OQ/PQ) and maintaining compliant documentation. Working knowledge of cGMP, GDP, and Quality System requirements. Cleanroom experience highly preferred. Why Join Us? This is an opportunity to make a direct impact on manufacturing performance, product quality, and operational excellence while working alongside a collaborative team in a highly regulated, innovative environment.

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