About this role
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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