Drug Substance Process Engineer — Tech Transfer & Scale-Up

Merck & Co.; Elkton (VA); On-site; USD 87,300 - 137,400; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical insurance

Dental insurance

Vision insurance

401(k)

Job summary

Merck & Co. is seeking a Process Engineer, Technical Operations - Drug Substance to join our growing API manufacturing team in the U.S.

You will support capital projects, process development, and technology transfer while driving process optimization and compliance with cGMP standards. The role emphasizes cross-functional collaboration with R&D, Quality, Engineering, and Supply Chain, enabling rapid tech transfer and scalable manufacturing.

Qualifications

• Degree in Chemical Engineering, Chemistry, or related discipline.
• 2-5+ years’ experience in API manufacturing, process development, or related pharmaceutical environment.
• Exposure to API processing operations and scale‑up.
• Understanding of cGMP manufacturing and regulatory expectations.
• Experience in one or more of: process support, technology transfer, manufacturing operations.
• Strong analytical and problem‑solving capability.
• Ability to analyze data and make sound technical decisions.
• Effective communication and collaboration across cross‑functional teams.
• Ability to manage priorities, meet deadlines, and deliver quality outcomes.
• Proactive, self‑driven approach to continuous improvement.

Responsibilities

• Support the Capital Project Team, contributing to design, commissioning, qualification, and startup readiness.
• Provide technical support for API manufacturing processes, including: chemical synthesis, purification and isolation, crystallization and drying operations.
• Take ownership of assigned process equipment and manufacturing processes.
• Support process scale‑up, technology transfer, and validation activities (e.g., pre‑PPQ, PPQ).
• Analyze process data to support performance monitoring, troubleshooting, and improvement.
• Provide on‑the‑floor technical support during manufacturing campaigns.
• Support execution of technology transfers for new products and processes into the facility.
• Partner with global R&D and receiving sites to ensure effective process knowledge transfer.
• Contribute to process fit assessments, scale‑up readiness, and manufacturability evaluations.
• Support development and review of batch documentation and process instructions.
• Assist in integration of new technologies into manufacturing operations.
• Partner with Manufacturing to support safe, efficient, and reliable plant performance.
• Identify and implement improvements in process robustness, product quality, and plant performance.
• Support activities related to operational excellence and cost reduction.
• Contribute to cleaning and turnaround optimization activities.
• Assist in deviation investigations, root cause analysis, and implementation of CAPAs.
• Monitor process performance, yields, and cycle times to identify improvement opportunities.
• Drive or participate in continuous improvement initiatives focused on yield, throughput, cycle time, and cost.

Skills

Analytical thinking

Problem-solving

Communication

Cross-functional collaboration

Prioritization

Education

Bachelor's in Chemical Engineering, Chemistry, or related

Job description

Merck & Co. is seeking a Process Engineer, Technical Operations - Drug Substance to join our growing API manufacturing team in the U.S.

You will support capital projects, process development, and technology transfer while driving process optimization and compliance with cGMP standards. The role emphasizes cross-functional collaboration with R&D, Quality, Engineering, and Supply Chain, enabling rapid tech transfer and scalable manufacturing.