Senior Operations Engineer

Merck; Elkton (VA); On-site; USD 110,000 - 160,000; Full time

Job summary

Merck, a premier research-intensive biopharmaceutical company, is seeking a Senior Operations Engineer - Drug Product for its new small molecule facility in Elkton, Virginia. You will join a team driving commissioning, qualification, and startup activities to enable safe, compliant, and efficient operations.

The role requires 5+ years in Drug Product/SDI manufacturing, strong GMP knowledge, and proven cross-functional collaboration.

Qualifications

• Bachelor’s degree in Chemical Engineering or related technical discipline required.
• Minimum 5 years of experience in Drug Product/SDI manufacturing, including operations and technical operations.
• Strong knowledge of GMP, quality, and regulatory expectations in pharmaceutical manufacturing.
• Proven ability to lead cross-functional teams and drive continuous improvement.

Responsibilities

• Support commissioning, qualification, start-up, and operational readiness for the new DP Small Molecule facility in Elkton, VA.
• Partner with Operations, Engineering, Quality, Technical Operations, Supply Chain, and other stakeholders to ensure safe, compliant start-up.
• Provide technical and operational support during equipment and process start-up, troubleshooting, and optimization.

Skills

Adaptability

Analytical Problem Solving

cGMP Compliance

Chemical Engineering

Cross-Functional Project Management

Data Analysis

Education

Bachelor’s degree in Chemical Engineering

Job description

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.

Job Purpose:

The Senior Operations Engineer - Drug Product supports the DP and SDI Integrated Product Team (IPT) in the commissioning, qualification, start-up, and operational readiness of the new Small Molecule manufacturing facility in Elkton, Virginia. This role partners with cross-functional teams to help ensure safe, compliant, and efficient operations during project execution and through ongoing manufacturing. In addition, the DP Operations Engineer helps coordinate and prioritize improvement activities and areas of focus across the IPT, supporting continuous improvement and operational excellence as the facility transitions into routine operations.

Primary Responsibilities:

• Support commissioning, qualification, start-up, and operational readiness activities for the new DP Small Molecule facility in Elkton, VA.
• Partner with Operations, Engineering, Quality, Technical Operations, Supply Chain, and other stakeholders to support safe, compliant, and effective plant start-up.
• Provide technical and operational support during equipment and process start-up, troubleshooting, and optimization activities.
• Support technology transfer and implementation of commercial manufacturing processes into the new facility.
• Help define, implement, and improve operating practices, standard work, procedures, and routines that support reliable and compliant operations.
• Coordinate and prioritize improvement activities and key areas of focus within the IPT in alignment with business objectives and operational performance goals.
• Use our company Production System (MPS) tools and lean principles, including Kaizen, 5S, visual management, and Standard Work, to identify and support improvement opportunities.
• Help embed best practices across shifts, functions, and workstreams to promote consistency, efficiency, and strong operational execution.
• Support a culture of safety, quality, compliance, accountability, and continuous improvement.
• Act as a delegate for the Production Lead when needed, supporting continuity of leadership and cross-functional coordination.
• Contribute to an inclusive, collaborative, and performance-driven work environment.

Minimum Required Education, Experience:

• Bachelor’s degree required. Chemical Engineering, Pharmaceutical Engineering, Biochemical Engineering, Chemistry, or a related technical discipline preferred.
• Minimum 5 years of experience in Drug Product/SDI manufacturing, to include operations, technical operations
• Experience working in a cross-functional manufacturing, technical, or operational setting.
• Experience contributing to operational improvement, troubleshooting, process support, or start-up-related activities.
• Working knowledge of GMP, quality, and compliance expectations in pharmaceutical manufacturing.
• Strong problem-solving, communication, collaboration, and organizational skills.
• Ability to work effectively across Operations, Engineering, Quality, and Technical teams.
• Ability to prioritize work in a dynamic, fast-paced environment.
• Demonstrated commitment to safety, operational excellence, and continuous improvement.

Preferred Qualifications:

• Experience supporting commissioning, qualification, start-up, or validation activities.
• Experience in a greenfield or new facility start-up environment.
• Experience with technology transfer and implementation of commercial manufacturing processes.
• Experience applying lean tools and methodologies, including Kaizen, 5S, and Standard Work.
• Experience coordinating activities across shifts, teams, or functions.
• Experience serving in a lead, coordinator, or delegate role supporting leadership continuity.
• Experience identifying improvement opportunities and helping implement practical solutions in a manufacturing environment.

Required Skills:

Adaptability, Adaptability, Analytical Problem Solving, cGMP Compliance, Chemical Engineering, Cross-Functional Project Management, Data Analysis, Decision Making, Engineering Support, Focused Improvement, Inventory Management, Leadership Theories, Lean Six Sigma Continuous Improvement, Manufacturing, Manufacturing Processes, Manufacturing Strategies, Manufacturing Systems, Manufacturing Technologies, Operational Quality, Operations Engineering, Personal Initiative, Pharmaceutical Process Development, Pharmaceutical Process Engineering, Process Improvements, Process Optimization