The Hardware Engineer II will join the Manufacturing Engineering group, whose responsibilities include supporting pilot manufacturing in the San Diego Innovation Center, primarily through equipment improvements. The engineer will support process development through equipment enhancements. The engineer will also support hands-on investigations and troubleshooting of process and equipment issues, collect data to document and drive improvements in support of product development, and implement measures to increase productivity. Provides direct operations equipment support to manufacturing areas and carries out hands-on investigation and troubleshooting of equipment issues. Uses structured problem solving, drives engineering studies using DMAIC methodology, and statistical data analysis. Collaborates and communicates with company interdepartmental groups including Quality Assurance, R&D, ITOT, and Process Engineering to provide documentation and operational support. Performs validation IQ/OQ/PQ protocols, test protocols, ensure equipment/processes meet specifications, performance, regulatory, and business requirements. Demonstrated experience in machine automation, test methods/standards, processes, and equipment maintenance, working knowledge of GMP standards and procedures.
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Job Type
Full-time
Career Level
Mid Level