Engineer II, Manufacturing Engineering Job at Thermo Fisher Scientific, Middletown, OH

  • Thermo Fisher Scientific
  • Middletown, OH

Job Description

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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