Engineer II, Manufacturing Engineering

Thermo Fisher Scientific

Manufacturing Engineer II supports clinical diagnostic reagent production in a cGMP, FDA-regulated environment. The role involves optimizing high-volume manufacturing operations, troubleshooting equipment and processes, and leading continuous improvement initiatives across formulation, filling, labeling, and packaging.

Responsibilities

Provide daily engineering support to improve quality, yield, throughput, and equipment reliability
Develop, optimize, and sustain manufacturing processes for diagnostic reagent production
Troubleshoot equipment and process issues using structured problem-solving methods
Monitor production data and implement continuous improvement initiatives targeting OEE and First Pass Yield
Support equipment qualification, process validation, CAPA activities, and documentation management

Requirements

Bachelor's degree in engineering or related technical discipline
Experience with manufacturing process optimization and equipment troubleshooting
Knowledge of cGMP, FDA regulations, and ISO 13485 requirements
Proficiency with structured problem-solving and root cause analysis methods
Experience with equipment qualification, validation protocols, and FMEA
Ability to work in regulated manufacturing environment with GMP compliance

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Vacancy posted a month ago

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