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Senior Process Engineer, Technical Operations - Small Molecule Drug Substance

Merck · Elkton, VA

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CMCFull-time$117k–$184kCompany career page

The apply link worked recently (not employer-confirmed).

Role summary

Senior Process Engineer role supporting small molecule active pharmaceutical ingredient manufacturing at a U.S.-based facility. The position involves technical leadership across process design, technology transfer, validation, and commercial production, with emphasis on operational excellence and regulatory compliance.

What they're looking for

  • Bachelor's degree in Chemical Engineering, Chemistry, or related discipline
  • 5+ years' experience in API manufacturing, process development, or pharmaceutical operations
  • Strong experience in API processing operations and scale-up to commercial manufacturing
  • Demonstrated involvement in technology transfer, validation, and process support activities
  • Working knowledge of cGMP manufacturing and regulatory expectations
  • Troubleshooting and process optimization experience in manufacturing environments
  • Analytical capability to interpret complex data and drive technical decisions

What you'll be doing

  • Provide technical leadership for API manufacturing processes including synthesis, purification, crystallization, and drying
  • Lead technology transfer execution, scale-up activities, and validation campaigns for new products and processes
  • Drive process optimization and continuous improvement initiatives focused on robustness, quality, yield, and throughput
  • Analyze process data, perform root-cause analysis, and resolve complex technical issues during manufacturing campaigns
  • Ensure compliance with cGMP standards, support regulatory inspections, and maintain high standards of documentation quality

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