Senior Process Engineer, Technical Operations - Small Molecule Drug Substance

Merck; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

Merck in the United States seeks a Senior Process Engineer, Technical Operations - Drug Substance to join our growing API manufacturing team. You will provide technical leadership for API processes from design through startup, technology transfer, and commercial manufacture, ensuring quality, safety, and operational excellence.

You will lead process scale-up, tech transfer, validation activities, and data-driven improvements, collaborating with cross-functional teams to drive robust process

Qualifications

• Degree in Chemical Engineering, Chemistry, or related discipline.
• Typically 5+ years' experience in API manufacturing or pharmaceutical operations.
• PhD may offset experience.
• Strong experience in API processing operations and scale-up to commercial manufacturing.
• Involvement in technology transfer, validation, and process support.
• Good understanding of cGMP.

Responsibilities

• Provide technical leadership for API manufacturing processes, including synthesis, purification, crystallization, and drying.
• Act as process owner / SME for assigned unit operations.
• Lead technical input to Capital Project Team and startup readiness.
• Lead or coordinate process scale-up, technology transfer, and validation activities.
• Analyze process data to drive data-driven decision-making and performance improvements.
• Provide advanced troubleshooting support during manufacturing campaigns.

Skills

API processing operations

Tech transfer leadership

Process scale-up

Data-driven decision making

Regulatory compliance

Education

Degree in Chemical Engineering or Chemistry

PhD may offset experience

Job description

Job Description

We have an exciting opportunity for a Senior Process Engineer, Technical Operations - Drug Substance to join our growing team.

At our company, we aspire to be the premier research-intensive biopharmaceutical company, using the power of leading-edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

Join a purpose-built, agile small molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably, receiving technology transfers from commercialization sites and fast-following into production with a focus on quality, safety, and operational excellence.

At our site, you'll be part of a team committed to creating a safe, environmentally responsible, and compliant workplace where people can do their best work. We are building deep small molecule expertise in the U.S., and we want team members who are excited to grow their skills, help improve how we operate, and contribute to a site positioned for future growth.

The successful candidate will provide technical leadership and process ownership supporting facility design, commissioning, qualification, and startup through to technology transfer, validation, and ongoing commercial manufacture of active pharmaceutical ingredients (APIs).

In this role, you will work as a key member of a cross-functional team, initially supporting the capital project and transitioning into process lead responsibilities across technology transfer and commercial manufacturing , driving technical excellence and operational performance.

Key Responsibilities

• Provide technical leadership for API manufacturing processes, including: Chemical synthesis Purification and isolation 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
• Drive process fit assessments, scale-up strategy, and manufacturability evaluations
• Own or guide development and optimization of batch documentation and process instructions
• Support integration and industrialization of new technologies into manufacturing operations
• Partner with Manufacturing to ensure safe, efficient, and reliable plant performance
• Identify, priorities, and implement improvements in: Process robustness Product quality Yield and throughput
• Lead or drive continuous improvement initiatives aligned with operational excellence objectives
• Use structured problem-solving approaches (e.g. RCA) to resolve deviations and recurring issues
• Monitor process performance, trends, and cycle times to proactively identify risks and opportunities
• Contribute to debottlenecking, cleaning, and turnaround optimization strategies
• Ensure all activities are conducted in compliance with cGMP, safety, and environmental standards
• Provide technical leadership in campaign preparation, execution, and post-campaign review
• Own or approve key batch record updates and process documentation improvements
• Support regulatory inspections and audits, providing technical input and ensuring inspection readiness
• Ensure high standards of data integrity and technical documentation quality
• Act as a technical representative within cross-functional teams including Manufacturing, Quality, Engineering, Supply Chain, and R&D
• Provide clear technical direction and influence decision-making across projects and operations
• Lead or contribute to cross-functional initiatives , driving alignment and delivery of key milestones
• Support knowledge sharing and best practice transfer across the network

Qualifications:

• Degree in Chemical Engineering, Chemistry, or related discipline
• Typically 5+ years' experience in API manufacturing, process development, or pharmaceutical operations
• (PhD may offset experience)
• Strong experience in API processing operations and scale-up to commercial manufacturing
• Demonstrated involvement in technology transfer, validation, and process support
• Good understanding of cG