Senior Drug Product Operations Engineer – Startup Site

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

Job summary

Merck in Elkton, VA seeks a Senior Operations Engineer - Drug Product to lead commissioning and start-up of a new small-molecule facility. You will coordinate cross-functional teams across Operations, Engineering, Quality and Technical Operations to ensure safe, compliant operations and rapid startup readiness.

The role emphasizes process transfer, continuous improvement, and the application of Lean/Six Sigma tools to achieve operational excellence and strong performance.

Qualifications

• Bachelor’s degree required in a technical discipline.
• Minimum 5 years of experience in Drug Product/SDI manufacturing.
• Experience in cross-functional manufacturing, technical operations.
• Knowledge of GMP, quality, and compliance in pharma.
• Strong problem-solving and communication skills.
• Ability to work across Operations, Engineering, Quality and Technical teams.

Responsibilities

• Support commissioning, qualification, start-up and readiness for the Elkton DP facility.
• Collaborate with Operations, Engineering, Quality and Supply Chain for safe start-up.
• Provide technical support during equipment and process start-up and troubleshooting.
• Support technology transfer and implementation of commercial processes.
• Define, implement and improve operating practices and standard work.
• Coordinate improvements and align with IPT objectives and performance goals.
• Utilize MPS tools, Kaizen, 5S, visual management and Standard Work for improvements.
• Embed best practices across shifts and functions for consistency and efficiency.
• Promote safety, quality, compliance and continuous improvement culture.
• Act as delegate for Production Lead to maintain leadership continuity.

Skills

Adaptability

Analytical thinking

cGMP Compliance

Chemical Engineering

Cross-functional PM

Data Analysis

Decision Making

Engineering Support

Lean Six Sigma

Manufacturing

Process Optimization

Operational Quality

Pharmaceutical Process Development

Process Engineering

Education

Bachelor’s degree in Chemical Engineering or related

Job description

Merck in Elkton, VA seeks a Senior Operations Engineer - Drug Product to lead commissioning and start-up of a new small-molecule facility. You will coordinate cross-functional teams across Operations, Engineering, Quality and Technical Operations to ensure safe, compliant operations and rapid startup readiness.

The role emphasizes process transfer, continuous improvement, and the application of Lean/Six Sigma tools to achieve operational excellence and strong performance.