Senior Process Engineer, Technical Operations - Small Molecule Drug Substance

Merck; Elkton (VA); On-site; USD 117,000 - 184,200; Full time

Benefits offered by this job

Annual bonus

Long‑term incentive

Medical, dental, vision

401(k) retirement plan

Paid holidays

Vacation and sick days

Job summary

Merck in Elkton, Virginia, seeks a Senior Process Engineer, Technical Operations – Drug Substance to join our growing team. You will lead API manufacturing processes, drive process scale‑up, and manage technology transfers, with emphasis on quality, safety, and regulatory compliance.

Ideal candidates bring 5+ years in API manufacturing or related pharma operations, strong data‑driven problem solving, and demonstrated ability to lead cross‑functional workstreams across development, operations,

Qualifications

• Degree in Chemical Engineering, Chemistry, or related discipline.
• Typically 5+ years’ API manufacturing, process development, or pharma operations.
• Strong experience in API processing operations and scale‑up to commercial manufacturing.
• Involvement in technology transfer, validation, and process support.
• Good understanding of cGMP manufacturing and regulatory expectations.
• Experience in troubleshooting and process optimization in manufacturing.

Responsibilities

• Provide technical leadership for API manufacturing processes including synthesis, purification, crystallization, and drying.
• Act as process owner/SME for unit operations and equipment.
• Lead input to Capital Project Team; support design reviews, commissioning, qualification, and startup readiness.
• Coordinate process scale‑up, tech transfer, and validation activities (pre‑PPQ, PPQ).
• Analyze process data to drive data‑driven decisions and improvements.
• Provide advanced troubleshooting support during campaigns.

Skills

Analytical skills

Leadership

Problem solving

Effective communication

Multi‑tasking

Education

Chemical Engineering degree

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 leading‑edge science to save and improve lives around the world. 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.

Key Responsibilities

Technical & Process Leadership

• 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.

Technology Transfer & Commercialization

• 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.

Process Optimization & Operational Excellence

• Partner with Manufacturing to ensure safe, efficient, and reliable plant performance.
• Identify, prioritize, 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.

Compliance & Documentation

• 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.

Cross‑functional Collaboration & Influence

• 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 cGMP manufacturing and regulatory expectations.
• Experience in troubleshooting and process optimization in a manufacturing environment.

Key Skills

• Strong analytical capability with ability to interpret complex data and drive decisions.
• Demonstrated ability to lead technical workstreams or projects.
• Excellent problem‑solving skills with structured, science‑based approach.
• Effective communicator with ability to influence cross‑functional stakeholders.
• Proven ability to manage multiple priorities and deliver results in a dynamic environment.
• Proactive, self‑driven mindset with strong focus on continuous improvement and ownership.

Our Culture

We keep the patient at the heart of everything we do and strive to deliver solutions for some of the world’s most challenging healthcare needs. Innovation happens when empowered individuals collaborate in an inclusive, high‑performing environment.

So, If You Are Ready To

• Play a key role in delivering new Drug Substance manufacturing capability.
• Take ownership of processes and drive technical and operational excellence.
• Develop as a technical leader in a high‑impact, technology‑driven environment.

Benefits

The salary range for this role is $117,000.00 – $184,200.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days. Full benefit details can be found at https://jobs.merck.com/us/en/compensation-and-benefits.

Equal Employment Opportunity Statement

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement. We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences, perspectives, skills and backgrounds.