Process Engineer, Technical Operations - Molecule Drug Substance

Process Engineer, Technical Operations – Drug Substance

Join our growing team at a purpose‑built, agile small molecule manufacturing site where you will help bring important medicines to patients in the U.S. The role focuses on providing technical support throughout the facility design, commissioning, qualification, technology transfer, validation and ongoing commercial manufacture of active pharmaceutical ingredients (APIs).

• Support the Capital Project Team with 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 for performance monitoring, troubleshooting and improvement.
• Provide on‑floor technical support during manufacturing campaigns.
• Coordinate 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.
• Assist in development and review of batch documentation and process instructions.
• Support integration of new technologies into manufacturing operations.
• Collaborate with Manufacturing to identify and implement improvements in process robustness, product quality and plant performance.
• Drive or participate in continuous‑improvement initiatives focused on yield and throughput, cycle‑time reduction, cost and efficiency improvements.
• Support campaign preparation, execution, post‑campaign review, batch record generation, review and optimization.
• Assist in regulatory and inspection readiness activities and ensure accurate documentation of process knowledge, investigations and improvements.

• Degree in Chemical Engineering, Chemistry or related discipline.
• Typically 2–5+ years of experience in API manufacturing, process development or related pharmaceutical environment (PhD may offset experience).
• Exposure to API processing operations and scale‑up.
• Understanding of cGMP manufacturing and regulatory expectations.
• Experience in one or more of the following: process support or development, 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.

• Salary range $87,300 – $137,400 and eligible for annual bonus and long‑term incentive, if applicable.
• Comprehensive package including medical, dental, vision healthcare and other insurance benefits for employee and family.
• Retirement benefits including 401(k).
• Paid holidays, vacation, compassionate and sick days.

Merck & Co., Inc. is an Equal Employment Opportunity Employer. Applicants will be treated fairly and discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics is prohibited. Merck complies with affirmative action requirements for protected veterans and individuals with disabilities.