Senior Process Engineer, Technical Operations – Small Molecule Drug Product (Spray Drying)

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

Benefits offered by this job

Annual bonus

Long-term incentive

Medical coverage

Retirement benefits (401(k))

Job summary

Merck is seeking a Senior Process Engineer, Technical Operations for Small Molecule Drug Product, focusing on spray drying. You will provide technical leadership and process ownership across design, qualification, technology transfer, and manufacturing of spray-dried materials.

The role requires interfacing with Manufacturing, QA, Engineering, and R&D to ensure robust transfer and scalable processes, while driving continuous improvement and data-driven decision making in a cGMP environment.

Qualifications

• Experience with spray drying and particle engineering.
• Solid understanding of scale-up for spray dryers (lab to commercial).
• Direct involvement in technology transfer and process validation (PPQ).
• Working knowledge of cGMP and regulatory expectations.

Responsibilities

• Provide technical leadership for spray-dried drug product processes and unit operations.
• Act as process owner/SME for spray drying and associated equipment.
• Lead or coordinate scale-up, tech transfer, and validation activities (PPQ).
• Interpret process and material data to drive data-driven decisions and improvements.
• Lead campaigns, prepare batch records, and support regulatory inspections.

Skills

Spray drying

Process ownership

Data interpretation

Cross-functional collaboration

Problem solving

Engineering leadership

Education

Degree in Chemical Engineering, Pharmaceutics, Pharmaceutical Sciences

Job description

Senior Process Engineer, Technical Operations – Small Molecule Drug Product (Spray Drying)

We have an exciting opportunity to join our growing team and help bring important medicines to patients in the U.S. You will provide technical leadership and process ownership supporting facility design, commissioning, qualification, technology transfer, validation, and ongoing commercial manufacture of spray‑dried materials.

Key Responsibilities

• Provide technical leadership for drug product intermediate manufacturing processes, including spray drying (solution and suspension systems), particle engineering and solid‑state control, powder handling, isolation, post‑processing, and downstream processing into dosage forms.
• Act as process owner/SME for spray drying and associated unit operations and equipment.
• Lead technical input to the Capital Project Team, supporting equipment selection, process design and control strategy development, and commissioning, qualification, and startup readiness.
• Lead or coordinate process scale‑up, technology transfer, and validation activities (e.g., PPQ).
• Interpret process and material data (PSD, morphology, residual solvent, solid‑state properties) to drive data‑driven decision‑making and performance improvements.
• Provide advanced troubleshooting support for spray drying and powder handling challenges.
• Lead or play a key role in execution of technology transfers for spray‑dried intermediates.
• Partner with global R&D and network sites to ensure robust transfer of formulation and particle engineering knowledge.
• Drive process fit and scalability assessments, spray dryer scale‑up strategy (lab → pilot → commercial), and equipment capability and process comparability evaluations.
• Own or guide development and optimization of batch documentation, process descriptions and control strategies.
• Support integration and industrialization of new particle engineering and enabled formulation technologies.
• Partner with Manufacturing to ensure safe, efficient, and reliable spray drying and intermediate processing operations.
• Identify, prioritize, and implement improvements in particle consistency, process robustness and yield, throughput and cycle time.
• Lead or drive continuous improvement initiatives aligned with operational excellence.
• Use structured problem‑solving approaches to resolve spray drying variability, powder handling challenges, and downstream processing impacts.
• Monitor process trends and critical quality attributes to proactively identify risks and optimization opportunities.
• Contribute to debottlenecking, cleaning optimization, and campaign efficiency improvements.
• Ensure compliance with cGMP, safety (including ATEX/containment where applicable), and environmental standards.
• Provide technical leadership in campaign preparation, execution, and post‑campaign review.
• Own or approve batch records, process specifications and control strategies for intermediates.
• Support regulatory inspections and audits, ensuring inspection‑ready processes and documentation.
• Ensure high standards of data integrity, particularly for materials characterization and process data.
• Act as a technical representative across Manufacturing, Quality, Engineering, Supply Chain, and R&D, providing clear technical direction and influencing decision‑making for product introduction and lifecycle management.
• Lead or contribute to cross‑functional initiatives, driving alignment and execution.
• Support knowledge sharing and best practice transfer across internal and external networks.

Qualifications

• Degree in Chemical Engineering, Pharmaceutics, Pharmaceutical Sciences, or related discipline.
• Typically 5+ years’ experience in drug product intermediate, spray drying, or pharmaceutical process development/manufacturing (PhD may offset experience).
• Strong experience in spray drying and/or particle engineering processes.
• Understanding of scale‑up principles for spray dryers (lab to commercial scale).
• Experience in solid‑state characterization and material science (PSD, morphology, amorphous/crystalline control).
• Demonstrated involvement in technology transfer, process validation (PPQ), and commercial manufacturing support.
• Working knowledge of cGMP and regulatory expectations.
• Experience with downstream processing into drug product (blending, compaction) is desirable.

Key Skills

• Strong analytical capability with ability to interpret process and material science data.
• Demonstrated ability to lead technical workstreams or process‑focused 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 in a dynamic manufacturing environment.
• Proactive, self‑driven mindset with strong focus on ownership and continuous improvement.

Benefits and Compensation

Salary range: $117,000.00 – $184,200.00. The successful candidate may be eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision, other insurance, retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days. More information is available at https://jobs.merck.com/us/en/compensation-and-benefits.

EEO 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. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment.