Process Engineer, Technical Operations - Small Molecule Drug Substance

Merck & Co., Inc; United States; On-site; USD 87,300 - 137,400; Full time

Benefits offered by this job

Medical, dental, vision coverage and其他

401(k) retirement benefits

Paid holidays and vacation

Compassionate and sick days

Job summary

Merck & Co., Inc. is seeking a Process Engineer, Technical Operations - Drug Substance to join our growing team in the United States. The role focuses on process support, technology transfer, and continuous improvement across API manufacturing and scale-up activities.

You will work within a compliant, patient-focused environment, collaborating across Manufacturing, Quality, Engineering, and R&D to ensure safe, reliable production and execution of capital projects.

Qualifications

• Degree in Chemical Engineering, Chemistry, or related discipline.
• 2–5+ years in API manufacturing or pharmaceutical environment.
• Exposure to API processing operations and scale-up.
• Understanding of cGMP manufacturing and regulatory expectations.

Responsibilities

• Provide technical and process support for API manufacturing processes, including chemical synthesis, purification, crystallization and drying operations.
• Take ownership of assigned process equipment and manufacturing processes; support scale-up, tech transfer, and validation activities (pre-PPQ, PPQ).
• Analyze process data for performance monitoring, troubleshooting and improvement; provide on-the-floor technical support during campaigns.
• Support technology transfers for new products and processes into the facility; collaborate with global R&D and receiving sites for knowledge transfer.
• Contribute to process fit assessments, scale-up readiness and manufacturability evaluations; assist in development and review of batch documentation.

Skills

Analytical thinking

Problem solving

Data analysis

Cross-functional collaboration

Time management

Education

Chemical Engineering, Chemistry, or related discipline

Job description

Job Description

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'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.

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 manage

Qualifications

• 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

Key Skills

• 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

Compensation

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

Benefits

We offer a comprehensive package of benefits. Available benefits include 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. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Equal Employment Opportunity

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 the EEOC Know Your Rights and EEOC GINA Supplement.