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
Vacancy posted 12 days ago
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