Senior Process Engineer, API Manufacturing & Tech Transfer

Merck; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

Merck in the United States seeks a Senior Process Engineer, Technical Operations - Drug Substance to join our growing API manufacturing team. You will provide technical leadership for API processes from design through startup, technology transfer, and commercial manufacture, ensuring quality, safety, and operational excellence.

You will lead process scale-up, tech transfer, validation activities, and data-driven improvements, collaborating with cross-functional teams to drive robust process

Qualifications

• Degree in Chemical Engineering, Chemistry, or related discipline.
• Typically 5+ years' experience in API manufacturing 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.

Responsibilities

• Provide technical leadership for API manufacturing processes, including synthesis, purification, crystallization, and drying.
• Act as process owner / SME for assigned unit operations.
• Lead technical input to Capital Project Team and startup readiness.
• Lead or coordinate process scale-up, technology transfer, and validation activities.
• Analyze process data to drive data-driven decision-making and performance improvements.
• Provide advanced troubleshooting support during manufacturing campaigns.

Skills

API processing operations

Tech transfer leadership

Process scale-up

Data-driven decision making

Regulatory compliance

Education

Degree in Chemical Engineering or Chemistry

PhD may offset experience

Job description

Merck in the United States seeks a Senior Process Engineer, Technical Operations - Drug Substance to join our growing API manufacturing team. You will provide technical leadership for API processes from design through startup, technology transfer, and commercial manufacture, ensuring quality, safety, and operational excellence.

You will lead process scale-up, tech transfer, validation activities, and data-driven improvements, collaborating with cross-functional teams to drive robust process