Biopharma Process Engineer – Tech Transfer & Scale‑Up

Merck; Elkton (VA); On-site; USD 71,900 - 113,200; Full time

Job summary

Merck is seeking an Assoc. Process Engineer, Technical Operations – Drug Substance to contribute to design, scale‑up, and tech transfer at our biopharmaceutical site in the United States.

The role emphasizes process support, data analysis, and collaboration with Manufacturing, Quality, Engineering, Supply Chain, and R&D teams. The ideal candidate has a chemical/process engineering background with 1–4+ years in API environments and a proactive approach to continuous improvement.

Qualifications

• Bachelor's degree in Chemical or Process Engineering or related discipline.
• 1–4+ years of 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 process support or development, technology transfer, or manufacturing operations.
• Strong analytical and problem‑solving capability.
• Ability to analyse 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 design, commissioning, qualification, and startup readiness.
• Provide technical support for API processing and scale‑up operations.
• Own assigned process equipment and manufacturing processes.
• Support technology transfer and validation activities (pre‑PPQ, PPQ).
• Analyze process data for performance monitoring and troubleshooting.
• Provide on‑floor technical support during campaigns.
• Assist in technology transfers for new products and processes.
• Partner with commercialisation and external sites for transfer.
• Contribute to process fit assessments and manufacturability evaluations.
• Support batch documentation and process instruction development.
• Assist integration of new technologies into manufacturing.
• Identify improvements in process robustness and product quality.
• Contribute to cleaning and turnaround optimisation.
• Assist deviation investigations and CAPA implementation.
• Monitor yields, cycle times, and process performance.
• Ensure compliance with cGMP, safety, and environmental standards.
• Participate in campaign preparation, safety and environmental reviews.
• Support campaign execution and post‑campaign review.
• Support batch record generation, review, and ongoing optimisation.
• Assist regulatory and inspection readiness activities.
• Document process knowledge, investigations, and improvements.
• Collaborate with Manufacturing, Quality, Engineering, Supply Chain, and R&D teams.
• Provide technical input into projects and process changes.
• Communicate complex projects across boundaries to all levels.

Skills

Analytical thinking

Data analysis

Effective communication

Self-driven with improvement mindset

Education

Bachelor’s degree in Chemical or Process Engineering

Job description

Merck is seeking an Assoc. Process Engineer, Technical Operations – Drug Substance to contribute to design, scale‑up, and tech transfer at our biopharmaceutical site in the United States.

The role emphasizes process support, data analysis, and collaboration with Manufacturing, Quality, Engineering, Supply Chain, and R&D teams. The ideal candidate has a chemical/process engineering background with 1–4+ years in API environments and a proactive approach to continuous improvement.