API Operations Engineer — Small Molecule Startup

Merck; Elkton (VA); On-site; USD 96,000 - 151,000; Full time

Job summary

Merck in Elkton, Virginia is establishing a new Small Molecule manufacturing facility. The API Operations Engineer will support commissioning, qualification, start-up, and operational readiness, partnering with quality, engineering, operations, and technical teams to ensure safe and compliant first production runs.

This role emphasizes continuous improvement using lean tools (Kaizen, 5S, Standard Work) and active problem solving across shifts and functions to enable reliable, high-quality

Qualifications

• Bachelor’s degree in Chemical Engineering, Pharmaceutical Engineering, Biochemical Engineering, Chemistry, or related technical discipline.
• Minimum 5 years of experience in drug substance/API manufacturing, operations, technical operations, or related manufacturing environment.
• Experience in 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.

Responsibilities

• Support commissioning, qualification, start-up, and operational readiness activities for the new API 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.

Job description

Merck in Elkton, Virginia is establishing a new Small Molecule manufacturing facility. The API Operations Engineer will support commissioning, qualification, start-up, and operational readiness, partnering with quality, engineering, operations, and technical teams to ensure safe and compliant first production runs.

This role emphasizes continuous improvement using lean tools (Kaizen, 5S, Standard Work) and active problem solving across shifts and functions to enable reliable, high-quality