Senior Process Engineer - API Operations & Tech Transfer

Merck; Elkton (VA); On-site; USD 117,000 - 184,200; Full time

Benefits offered by this job

Annual bonus

Long‑term incentive

Medical, dental, vision

401(k) retirement plan

Paid holidays

Vacation and sick days

Job summary

Merck in Elkton, Virginia, seeks a Senior Process Engineer, Technical Operations – Drug Substance to join our growing team. You will lead API manufacturing processes, drive process scale‑up, and manage technology transfers, with emphasis on quality, safety, and regulatory compliance.

Ideal candidates bring 5+ years in API manufacturing or related pharma operations, strong data‑driven problem solving, and demonstrated ability to lead cross‑functional workstreams across development, operations,

Qualifications

• Degree in Chemical Engineering, Chemistry, or related discipline.
• Typically 5+ years’ API manufacturing, process development, or pharma operations.
• 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 manufacturing.

Responsibilities

• Provide technical leadership for API manufacturing processes including synthesis, purification, crystallization, and drying.
• Act as process owner/SME for unit operations and equipment.
• Lead input to Capital Project Team; support design reviews, commissioning, qualification, and startup readiness.
• Coordinate process scale‑up, tech transfer, and validation activities (pre‑PPQ, PPQ).
• Analyze process data to drive data‑driven decisions and improvements.
• Provide advanced troubleshooting support during campaigns.

Skills

Analytical skills

Leadership

Problem solving

Effective communication

Multi‑tasking

Education

Chemical Engineering degree

Job description

Merck in Elkton, Virginia, seeks a Senior Process Engineer, Technical Operations – Drug Substance to join our growing team. You will lead API manufacturing processes, drive process scale‑up, and manage technology transfers, with emphasis on quality, safety, and regulatory compliance.

Ideal candidates bring 5+ years in API manufacturing or related pharma operations, strong data‑driven problem solving, and demonstrated ability to lead cross‑functional workstreams across development, operations,