Process Engineer, Technical Operations - Small Molecule Drug Substance

Biopharma Careers; Elkton (KY); On-site; USD 87,000 - 137,000; Full time

Job summary

Merck & Co. in the United States is seeking a Process Engineer, Technical Operations – Drug Substance to join our growing team.

This role provides technical support for API manufacturing, technology transfers, and process optimization within a fast-paced small‑molecule site. You will collaborate across Manufacturing, Quality, Engineering, and R&D to ensure cGMP compliance, robustness, and efficient campaigns.

Qualifications

• Degree in Chemical Engineering, Chemistry, or related discipline.
• Typically 2–5+ years’ API manufacturing or process development experience.
• Exposure to API processing, scale‑up, and cGMP expectations.

Responsibilities

• Provide technical support for API manufacturing processes, including chemical synthesis, purification, crystallization, and drying.
• Support capital projects, commissioning, qualification, technology transfer, and validation activities.
• Analyze process data, monitor performance, and drive continuous improvement.
• Collaborate with Manufacturing, Quality, Engineering, Supply Chain, and R&D teams.
• Ensure compliance with cGMP, safety, and environmental standards.

Skills

Chemical Engineering

API manufacturing

Process development

cGMP knowledge

Cross-functional collaboration

Education

Bachelor's degree in Chemical Engineering or related

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.

The successful candidate will provide technical support for the facility design, commissioning, qualification through technology transfer, validation and ongoing commercial manufacture of active pharmaceutical ingredients (APIs).

In this role, you will work as part of a cross‑functional team, initially supporting the capital project and transitioning to technology transfer and commercial manufacturing, while building deep technical expertise and contributing to operational excellence.

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

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

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

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. We believe innovation happens when empowered individuals collaborate in an inclusive, high‑performing environment.

So, if you are ready to:

• Support delivery of new Drug Substance manufacturing capability
• Develop your expertise in API processing and commercialization
• Contribute to a high-impact, technology-driven manufacturing environment

Required Skills

• Adaptability
• Adaptability
• Biopharmaceutical Industry
• Biopharmaceuticals
• Biopharmaceutics
• Change Control Management
• Chemical Engineering
• Continuous Process Improvement
• Cross‑Functional Collaboration
• Data Analysis
• Deviation Investigations
• Equipment Troubleshooting
• Good Manufacturing Practices (GMP)
• Lean Manufacturing
• New Product Development
• Operational Excellence
• Performance Monitoring
• Personal Initiative
• Process Optimization
• Professional Integrity
• Project Management
• Project Manufacturing
• Root Cause Analysis (RCA)
• Teamwork
• Technical Writing {+ 2 more}

US and Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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: EEOC Know Your Rights EEOC GINA Supplement

Inclusivity Statement

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. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

Salary

The salary range for this role is $87,300.00 - $137,400.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

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 .

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 for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Merck & Co. Search Firm Block

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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

Job Posting End Date

10/1/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID

R405916