Associate Process Engineer, Drug Substance Manufacturing

Merck; Elkton (VA); On-site; USD 72,000 - 113,000; Full time

Job summary

Merck is seeking an Assoc. Process Engineer, Technical Operations - Drug Substance to join our team focused on API manufacturing at a U.S. site. The role emphasizes supporting capital projects, tech transfer, and ongoing production with strong emphasis on quality and regulatory compliance.

The candidate will collaborate with Manufacturing, Quality, Engineering and R&D to ensure robust processes, documentation, and manufacturing readiness for new drug substance programs and scale-up activities.

Qualifications

• Bachelor degree in Chemical or Process Engineering or related discipline.
• 1-4+ 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: Process support or development, Technology transfer, Manufacturing operations.

Responsibilities

• Support the Capital Project Team, contributing to design, commissioning, qualification, and startup readiness.
• Knowledge and subject matter expertise on API processing unit operations and scale up opportunities; identify constraints and validate through piloting and validation.
• Take ownership of assigned process equipment and manufacturing processes.
• Support technology transfer and validation activities (e.g. pre-PPQ, PPQ).
• Analyse process data to support performance monitoring, troubleshooting, and improvement.
• Provide on-the-floor technical support during manufacturing campaigns.
• Support development and review of batch documentation and process instructions.
• Assist in integration of new technologies into manufacturing operations.

Skills

API processing

Process development

Technology transfer

Manufacturing operations

cGMP knowledge

Education

Bachelor's degree in Chemical or Process Engineering

Job description

Merck is seeking an Assoc. Process Engineer, Technical Operations - Drug Substance to join our team focused on API manufacturing at a U.S. site. The role emphasizes supporting capital projects, tech transfer, and ongoing production with strong emphasis on quality and regulatory compliance.

The candidate will collaborate with Manufacturing, Quality, Engineering and R&D to ensure robust processes, documentation, and manufacturing readiness for new drug substance programs and scale-up activities.