Senior Process Engineer, API Ops & Tech Transfer

Biopharma Careers; Elkton (KY); On-site; USD 117,000 - 184,000; Full time

Job summary

Merck & Co., Inc. seeks a Senior Process Engineer, Technical Operations – Drug Substance to provide technical leadership across API manufacturing, process development, and technology transfer.

You will work on scale-up, validation, and post-transfer operations to support commercial production of APIs. You will collaborate with Manufacturing, Quality, Engineering, and R&D to ensure robust processes, data-driven improvements, and compliant documentation.

Qualifications

• Degree in Chemical Engineering, Chemistry, or related discipline.
• Typically 5+ years’ experience in API manufacturing, process development, or pharmaceutical operations.
• PhD may offset experience.
• Strong experience in API processing operations and scale-up to commercial manufacturing.
• Involvement in technology transfer, validation, and process support.
• Good understanding of cGMP manufacturing and regulatory expectations.
• Experience in troubleshooting and process optimization in a manufacturing environment.

Responsibilities

• Provide technical leadership for API manufacturing processes, including chemical synthesis, purification and isolation, crystallization and drying operations.
• Act as process owner/SME for assigned unit operations, equipment, or product processes.
• Lead or coordinate process scale-up, technology transfer, and validation activities (e.g. pre-PPQ, PPQ).
• Analyze and interpret process data to drive data-driven decision-making and performance improvements.
• Provide advanced troubleshooting support during manufacturing campaigns, resolving complex technical issues.
• Lead or play a key role in execution of technology transfers for new products and processes into the facility.
• Partner with global R&D and network sites to ensure robust process knowledge transfer and right-first-time startup.
• Drive process fit assessments, scale-up strategy, and manufacturability evaluations.
• Own or guide development and optimization of batch documentation and process instructions.
• Support integration and industrialization of new technologies into manufacturing operations.
• Partner with Manufacturing to ensure safe, efficient, and reliable plant performance.
• Identify and implement improvements in process robustness, product quality, yield and throughput.

Skills

Technical leadership

Data-driven decisions

Process optimization

Cross-functional collaboration

Analytical thinking

Education

Chemical Engineering or Chemistry degree

Job description

Merck & Co., Inc. seeks a Senior Process Engineer, Technical Operations – Drug Substance to provide technical leadership across API manufacturing, process development, and technology transfer.

You will work on scale-up, validation, and post-transfer operations to support commercial production of APIs. You will collaborate with Manufacturing, Quality, Engineering, and R&D to ensure robust processes, data-driven improvements, and compliant documentation.