Associate Process Engineer, Technical Operations - Small Molecule Drug Substance

Merck & Co.; Elkton (VA); On-site; USD 71,900 - 113,200; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Paid holidays

Job summary

Merck & Co. in Elkton, VA, is seeking an Assoc. Process Engineer, Technical Operations - Drug Substance to support facility design, commissioning, qualification, and technology transfer of APIs.

You will work on cross‑functional teams, advancing capital projects and transitioning to commercial manufacturing with emphasis on process robustness and quality. The role demands strong analytical skills, data‑driven problem solving, effective communication, and adherence to cGMP standards within a

Qualifications

• Bachelor’s degree in chemical, process engineering or related discipline.
• 1–4+ years’ experience in API manufacturing, process development, or pharmaceutical environment.
• Exposure to API processing operations and scale‑up.
• Understanding of cGMP manufacturing and regulatory expectations.
• Experience in process support, technology transfer, or manufacturing operations.

Responsibilities

• Provide technical support for facility design, commissioning, qualification through technology transfer, validation and ongoing manufacture of APIs.
• Support API processing unit operations, scale‑up, piloting, and validation.
• Own assigned process equipment and manufacturing processes.
• Assist in technology transfer, batch documentation, and process instructions.
• Collaborate with Manufacturing, Quality, Engineering, Supply Chain, and R&D teams.

Skills

Analytical thinking

Problem solving

Data analysis

Cross-functional collaboration

Effective communication

Time management

Education

Bachelor's Degree in Chemical Engineering or related

Job description

Job Description

We have an exciting opportunity for an Assoc. 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 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.
• Apply knowledge and subject‑matter expertise on API processing unit operations and scale‑up opportunities to identify and overcome constraints and tests, ensuring successful demonstration of processes through piloting and validation.
• Take ownership of assigned process equipment and manufacturing processes.
• Support technology transfer and validation activities (e.g., pre‑PPQ, PPQ).
• Analyse process data to support performance monitoring, troubleshooting, and improvement.
• Provide on‑the‑floor technical support during manufacturing campaigns.

Technology Transfer & Commercialisation

• Support execution of technology transfers for new products and processes into the facility.
• Partner with Commercialization and external 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 Optimisation & Operational Excellence

• Identify and implement improvements in process robustness, product quality, and plant performance.
• Demonstrate aptitude for technical problem solving, obtaining positive outcomes.
• Contribute to cleaning and turnaround optimisation activities.
• Assist in deviation investigations, root cause analysis, and implementation of CAPAs.
• Monitor process performance, yields, and cycle times to identify improvement opportunities.

Compliance & Documentation

• Ensure all activities are conducted in compliance with cGMP, safety, and environmental standards.
• Participate in campaign preparation, safety and environmental reviews, batch sheet reviews.
• Support campaign preparation, execution, and post‑campaign review activities.
• Support batch record generation, review, and ongoing optimisation.
• 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.
• Communicate effectively across boundaries, conveying complex projects to people at all levels of the organization in a compliant manner.

Qualifications

• Bachelor’s Degree in Chemical, Process Engineering or related discipline.
• 1–4+ years’ experience in API manufacturing, process development, or a 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 or development, technology transfer, manufacturing operations.

Key Skills

• Strong analytical and problem‑solving capability.
• Ability to analyse 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 commercialisation.
• Contribute to a high‑impact, technology‑driven manufacturing environment.

… we encourage you to apply.

Benefits

We offer a comprehensive package of benefits: 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.

Compensation

Salary range: $71,900.00 – $113,200.00. The salary range is the lowest to highest range we believe we would pay for this role and is based on factors including education, qualifications, certifications, experience, skills, geographic location, government requirements, and business needs.

The successful candidate will be eligible for an annual bonus and long‑term incentive, if applicable.

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. We comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit EEOC Know Your Rights and EEOC GINA Supplement.

Employment Information

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): N/A.

Job posting end date: 07/25/2026.