Process Engineer, Technical Operations - Small Molecule Drug Substance

Merck & Co.; Elkton (VA); On-site; USD 87,300 - 137,400; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical insurance

Dental insurance

Vision insurance

401(k)

Job summary

Merck & Co. is seeking a Process Engineer, Technical Operations - Drug Substance to join our growing API manufacturing team in the U.S.

You will support capital projects, process development, and technology transfer while driving process optimization and compliance with cGMP standards. The role emphasizes cross-functional collaboration with R&D, Quality, Engineering, and Supply Chain, enabling rapid tech transfer and scalable manufacturing.

Qualifications

• Degree in Chemical Engineering, Chemistry, or related discipline.
• 2-5+ years’ 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 one or more of: process support, 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.

Responsibilities

• Support the Capital Project Team, contributing to 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 to support performance monitoring, troubleshooting, and improvement.
• Provide on‑the‑floor technical support during manufacturing campaigns.
• Support 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.
• Support development and review of batch documentation and process instructions.
• Assist in integration of new technologies into manufacturing operations.
• Partner with Manufacturing to support safe, efficient, and reliable plant performance.
• Identify and implement improvements in process robustness, product quality, and plant performance.
• Support activities related to operational excellence and cost reduction.
• Contribute to cleaning and turnaround optimization activities.
• Assist in deviation investigations, root cause analysis, and implementation of CAPAs.
• Monitor process performance, yields, and cycle times to identify improvement opportunities.
• Drive or participate in continuous improvement initiatives focused on yield, throughput, cycle time, and cost.

Skills

Analytical thinking

Problem-solving

Communication

Cross-functional collaboration

Prioritization

Education

Bachelor's in Chemical Engineering, Chemistry, or related

Job description

Process Engineer, Technical Operations - Drug Substance

We have an exciting opportunity for a 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 will 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.

Key Responsibilities

Technical & Process Support

• Support the Capital Project Team, contributing to 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 to support performance monitoring, troubleshooting, and improvement.
• Provide on‑the‑floor technical support during manufacturing campaigns.

Technology Transfer & Commercialization

• Support 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.
• Support development and review of batch documentation and process instructions.
• Assist in integration of new technologies into manufacturing operations.

Process Optimization & Operational Excellence

• Partner with Manufacturing to support safe, efficient, and reliable plant performance.
• Identify and implement improvements in process robustness, product quality, and plant performance.
• Support activities related to operational excellence and cost reduction.
• Contribute to cleaning and turnaround optimization activities.
• Assist in deviation investigations, root cause analysis, and implementation of CAPAs.
• Monitor process performance, yields, and cycle times to identify improvement opportunities.
• Drive or participate in continuous improvement initiatives focused on:
  • Yield and throughput
  • Cycle time reduction
  • Cost and efficiency improvements

Compliance & Documentation

• Ensure all activities are conducted in compliance with cGMP, safety, and environmental standards.
• Support campaign preparation, execution, and post‑campaign review activities.
• Support batch record generation, review, and ongoing optimization.
• Assist in regulatory and inspection readiness activities.
• Ensure accurate documentation of process knowledge, investigations, and improvements.

Cross‑functional Collaboration

• Work closely with Manufacturing, Quality, Engineering, Supply Chain, and R&D teams.
• Provide technical input into projects, process changes, and ongoing operations.
• Participate in cross‑functional teams supporting product introduction and lifecycle management.

Qualifications

To excel in this role, you will have:

• Degree in Chemical Engineering, Chemistry, or related discipline.
• Typically 2‑5+ years’ 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:
  • 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.

Benefits & Compensation

Salary range: $87,300.00 - $137,400.00. The successful candidate will also be eligible for annual bonus and long‑term incentive, if applicable.

We offer a comprehensive benefits package that includes medical, dental, vision, healthcare, and other insurance benefits (for employee and family), retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days.

Location Requirements

US and Puerto Rico Residents Only. San Francisco Residents Only – we will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance. Los Angeles Residents Only – we will consider applicants, including those with criminal histories, in compliance with the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Employment Details

• Employee status: Regular.
• Relocation: Domestic.
• Visa sponsorship: No.
• Travel requirements: 10%.
• Flexible work arrangements: Not Applicable.
• Shift: 1st – Day.
• Valid driving license: No.
• Hazardous material(s): NA.

Equal Employment Opportunity Statement

We are 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 legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

EEOC Know Your Rights and EEOC GINA Supplement information is provided for your reference.