Drug Substance Process Engineer - Tech Ops & Scale-Up

Merck; Elkton (VA); On-site; USD 87,300 - 137,400; Full time

Job summary

Merck in the United States is seeking a Process Engineer, Technical Operations – Drug Substance to join our growing team. You will provide technical support for API manufacturing processes and contribute to technology transfer and commercial manufacturing, with a focus on quality and operational excellence.

The role emphasizes cross‑functional collaboration with Manufacturing, Quality, Engineering, and R&D, data‑driven decisions, and efforts to improve yield, cycle time, and process robustness

Qualifications

• Degree in Chemical Engineering, Chemistry, or related discipline.
• 2–5+ years’ API manufacturing or process development experience.
• Exposure to API processing operations and scale-up.
• Understanding of cGMP manufacturing and regulatory expectations.
• Experience in process support, technology transfer, or manufacturing operations.

Responsibilities

• Provide technical support for API manufacturing processes (synthesis, purification, crystallization, drying).
• Own assigned process equipment and manufacturing steps.
• Support scale-up, technology transfer, and validation activities (pre-PPQ, PPQ).
• Analyze process data for performance monitoring and troubleshooting.
• Collaborate cross-functionally with Manufacturing, Quality, Engineering, and R&D.
• Assist in campaign preparation, batch documentation, and continuous improvement.

Skills

Analytical thinking

Data analysis

Cross-functional collaboration

Prioritization & deadlines

Continuous improvement

Education

Chemical Engineering

Chemistry

Job description

Merck in the United States is seeking a Process Engineer, Technical Operations – Drug Substance to join our growing team. You will provide technical support for API manufacturing processes and contribute to technology transfer and commercial manufacturing, with a focus on quality and operational excellence.

The role emphasizes cross‑functional collaboration with Manufacturing, Quality, Engineering, and R&D, data‑driven decisions, and efforts to improve yield, cycle time, and process robustness