Pharma Manufacturing Process Engineer — Drive Innovation

Merck; Durham (NC); On-site; USD 87,000 - 137,000; Full time

Job summary

Merck in Durham, NC seeks a Growth and Improvement-minded Specialist, Engineering to drive strategic priorities within Technical Operations. You will collect data, develop solutions, and exercise independent judgment on projects of varying scope.

Responsibilities include root cause analysis for thawing/pooling/filling equipment, documenting process changes, and supporting QA/regulatory activities. A BS in Engineering with 2 years in pharma is required.

Qualifications

• BS in Engineering or related field with 2 years in pharma ops/technical services/quality operations.
• 2+ years of relevant industrial experience.
• Experience in GMP pharmaceutical environments.

Responsibilities

• Provide technical assistance to thawing/pooling/filling equipment for in-line products; lead root cause investigations.
• Write scientific justification for proposed changes; design experiments and review data.
• Support QA/regulatory activities, site inspections, NDA supplements, and environmental issues.
• Ensure accuracy of Process Descriptions and CP Memos with in-depth process knowledge.
• Complete process eng/ development tasks per safety, quality, and regulatory policies.
• Review literature on aseptic filling/lyophilization to drive improvements.
• Support design, machinability evaluation, and qualification of new or modified equipment components.
• Provide on-shift support during critical runs (Aseptic Process Simulation, protocol execution).
• Author process change controls and implement equipment/process changes.

Skills

Root cause analysis

Technical troubleshooting

Data interpretation

Written communication

Cross-functional collaboration

Education

BS in Engineering

Tools

Process equipment

Job description

Merck in Durham, NC seeks a Growth and Improvement-minded Specialist, Engineering to drive strategic priorities within Technical Operations. You will collect data, develop solutions, and exercise independent judgment on projects of varying scope.

Responsibilities include root cause analysis for thawing/pooling/filling equipment, documenting process changes, and supporting QA/regulatory activities. A BS in Engineering with 2 years in pharma is required.