Senior Process Engineer, API Tech Transfer & Operations

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

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck in the United States is seeking a Senior Process Engineer, Technical Operations - Drug Substance to lead API manufacturing processes and technology transfer from development to commercial production. You will own critical unit operations, drive process scale-up, and ensure cGMP compliance within a fast-paced small-molecule manufacturing site.

Successful candidates will combine technical leadership with hands-on problem solving, partnering with R&D, QA, and Manufacturing to optimize yield,

Qualifications

• Degree in Chemical Engineering, Chemistry, or related discipline.
• 5+ years of API manufacturing, process development, or pharma operations.
• Experience in API processing, scale-up to commercial manufacturing.
• Involvement in technology transfer, validation, and process support.
• Knowledge of cGMP manufacturing and regulatory expectations.
• Troubleshooting and process optimization in manufacturing.

Responsibilities

• Provide technical leadership for API manufacturing processes, including chemical synthesis, purification, crystallization, and drying operations.
• Act as process owner/SME for assigned unit operations, equipment, or product processes.
• Lead technical input to the Capital Project Team, supporting design reviews, commissioning, qualification, and startup readiness.
• 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.

Skills

API processing

Scale-up

Technology transfer

cGMP

Data analysis

Education

Chemical Engineering

Job description

Merck in the United States is seeking a Senior Process Engineer, Technical Operations - Drug Substance to lead API manufacturing processes and technology transfer from development to commercial production. You will own critical unit operations, drive process scale-up, and ensure cGMP compliance within a fast-paced small-molecule manufacturing site.

Successful candidates will combine technical leadership with hands-on problem solving, partnering with R&D, QA, and Manufacturing to optimize yield,