Associate Process Engineer, Technical Operations - Small Molecule Drug Substance

Merck & Co., Inc; United States; On-site; USD 71,900 - 113,200; Full time

Benefits offered by this job

Medical insurance

Dental insurance

401(k) retirement plan

Job summary

Merck & Co., Inc is seeking an Associate Process Engineer, Technical Operations – Drug Substance to join its research‑intensive biopharmaceutical operations in the United States. You will support capital projects, technology transfer, and commercial manufacturing, contributing to quality, safety, and operational excellence.

The role emphasizes on‑the‑floor process support, scale‑up opportunities, and collaboration with Manufacturing, Quality, Engineering, Supply Chain, and R&D teams to drive

Qualifications

• Bachelor's Degree in Chemical or Process Engineering or a related discipline.
• 1–4+ years of API manufacturing or related pharmaceutical experience.
• 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

• Support capital projects, design, commissioning, qualification, and startup readiness.
• Provide SME on API processing unit operations and scale-up opportunities.
• Own assigned process equipment and manufacturing processes.
• Support technology transfer and validation activities (pre-PPQ, PPQ).
• Analyze process data to support performance monitoring, troubleshooting, and improvement.
• Provide on-floor technical support during manufacturing campaigns.
• Collaborate with Manufacturing, Quality, Engineering, Supply Chain, and R&D teams.

Skills

Analytical skills

Data analysis

Cross-functional collaboration

Communication

Time management

Education

Bachelor's Degree in Chemical or Process Engineering

Job description

Job Description

We have an exciting opportunity for an Associate Process Engineer, Technical Operations – Drug Substance to join our growing team at a research‑intensive biopharmaceutical company, using leading‑edge science to produce innovative health solutions.

As a member of a purpose‑built, agile small‑molecule manufacturing site, you will contribute to delivering important medicines to patients in the U.S. You will support capital projects, technology transfer, and commercial manufacturing, ensuring quality, safety, and operational excellence.

Key Responsibilities

Technical & Process Support

• Support the Capital Project Team, contributing to design, commissioning, qualification, and startup readiness.
• Provide subject‑matter expertise on API processing unit operations and scale‑up opportunities, identifying and overcoming constraints and tests to demonstrate 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).
• Analyze process data to support performance monitoring, troubleshooting, and improvement.
• Provide on‑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.
• Apply technical problem‑solving skills to obtain 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, and 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.
• Convey complex projects across boundaries with clear communication at all organisational levels.

Qualifications

• Bachelor's Degree in Chemical or Process Engineering or a related discipline.
• Typically 1–4+ years of 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 the following: process support or development, technology transfer, or 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.

Salary

$71,900.00 – $113,200.00 per year, based on qualifications, experience, and location.

Benefits

We offer a comprehensive package that includes medical, dental, vision, and other insurance benefits, retirement benefits (including 401(k)), paid holidays, vacation, compassionate and sick days. More details can be found at the company benefits website.

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.