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Associate Process Engineer, Technical Operations - Small Molecule Drug Substance

Merck
August 28, 2026
Full-time
On-site
Elkton, VA
Operations
Role: Associate Process Engineer in Technical Operations supporting drug substance manufacturing at a small molecule biopharma site. Objectives include providing technical support for facility design, commissioning, process validation, transfer, and ongoing production of APIs. Responsibilities encompass supporting capital projects, process development, scale-up, troubleshooting, process optimization, and ensuring cGMP compliance. Key tasks involve equipment ownership, data analysis, process validation activities, and cross-functional collaboration with Manufacturing, Quality, Engineering, and R&D teams. Qualifications: Bachelor's in Chemical or Process Engineering, 1-4+ years in API manufacturing, process development, or related pharma environment; experience in API processing, scale-up, and regulatory expectations. Skills: technical problem-solving, data analysis, effective communication, and cross-team collaboration. High-Value: small molecule APIs, cGMP manufacturing, process transfer, validation, with a focus on operational excellence and continuous improvement. Work setup: On-site with approximately 10% travel.