Associate Process Engineer, Technical Operations - Small Molecule Drug Substance

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

Job summary

Merck is seeking an Assoc. Process Engineer, Technical Operations – Drug Substance to contribute to design, scale‑up, and tech transfer at our biopharmaceutical site in the United States.

The role emphasizes process support, data analysis, and collaboration with Manufacturing, Quality, Engineering, Supply Chain, and R&D teams. The ideal candidate has a chemical/process engineering background with 1–4+ years in API environments and a proactive approach to continuous improvement.

Qualifications

• Bachelor's degree in Chemical or Process Engineering or related discipline.
• 1–4+ years of 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 process support or development, technology transfer, or manufacturing operations.
• 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.

Responsibilities

• Support design, commissioning, qualification, and startup readiness.
• Provide technical support for API processing and scale‑up operations.
• Own assigned process equipment and manufacturing processes.
• Support technology transfer and validation activities (pre‑PPQ, PPQ).
• Analyze process data for performance monitoring and troubleshooting.
• Provide on‑floor technical support during campaigns.
• Assist in technology transfers for new products and processes.
• Partner with commercialisation and external sites for transfer.
• Contribute to process fit assessments and manufacturability evaluations.
• Support batch documentation and process instruction development.
• Assist integration of new technologies into manufacturing.
• Identify improvements in process robustness and product quality.
• Contribute to cleaning and turnaround optimisation.
• Assist deviation investigations and CAPA implementation.
• Monitor yields, cycle times, and process performance.
• Ensure compliance with cGMP, safety, and environmental standards.
• Participate in campaign preparation, safety and environmental reviews.
• Support campaign execution and post‑campaign review.
• Support batch record generation, review, and ongoing optimisation.
• Assist regulatory and inspection readiness activities.
• Document process knowledge, investigations, and improvements.
• Collaborate with Manufacturing, Quality, Engineering, Supply Chain, and R&D teams.
• Provide technical input into projects and process changes.
• Communicate complex projects across boundaries to all levels.

Skills

Analytical thinking

Data analysis

Effective communication

Self-driven with improvement mindset

Education

Bachelor’s degree in Chemical or Process Engineering

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 a premier research‑intensive biopharmaceutical organization, using cutting‑edge science to improve lives worldwide. This small molecule manufacturing site focuses on operational excellence and rapid technology transfer from commercialization sites into production.

Key Responsibilities

• Support the Capital Project Team, contributing to design, commissioning, qualification, and startup readiness.
• Provide technical support for API processing unit operations and scale‑up opportunities, identifying and overcoming constraints.
• Take ownership of assigned process equipment and manufacturing processes.
• Support technology transfer and validation activities (e.g., pre‑PPQ, PPQ).
• Analyze process data to support performance monitoring, troubleshooting, and improvement.
• Provide on‑floor technical support during manufacturing campaigns.
• Assist in the execution of technology transfers for new products and processes into the facility.
• Partner with commercialisation teams 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.
• Identify and implement improvements in process robustness, product quality, and plant performance.
• 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.
• Ensure all activities comply 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.
• Work closely with Manufacturing, Quality, Engineering, Supply Chain, and R&D teams.
• Provide technical input into projects, process changes, and ongoing operations.
• Communicate complex projects across boundaries, conveying information to all levels.

Qualifications

• Bachelor’s degree in Chemical or Process Engineering or related discipline.
• Typically 1–4+ years of 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 process support or development, technology transfer, or manufacturing operations.
• 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.

Location Requirement

• US and Puerto Rico Residents Only.

Salary and Benefits

Salary range: $71,900.00 – $113,200.00 (based on education, experience, geographic location, and business needs).

Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days, and an annual bonus/long‑term incentive, if applicable.

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