Investigation & Deviation Engineer – GMP Manufacturing

Merck; West Point (PA); Hybrid; USD 117,000 - 184,000; Full time

Job summary

Merck is seeking a Senior Specialist, Engineering at the West Point site to lead investigations stemming from manufacturing deviations in live virus vaccine operations. The role focuses on root-cause analysis, corrective actions, and robust documentation, with cross-functional collaboration across safety, quality, automation, and production teams.

You will design experiments, support shop-floor troubleshooting, and drive continuous improvement within Deviation Management, while maintaining GMP

Qualifications

• Minimum four years post-bachelor's GMP manufacturing experience or MS with two years experience.
• Ability to drive results and foster accountability.
• Strong communication and collaboration skills.

Responsibilities

• Leads manufacturing investigations, identifying root cause and corrective actions.
• Examines issues from safety, compliance, automation, equipment, process and people perspectives.
• Provides technical support to manufacturing shop floor for problems.
• Designs experimental protocols using lab facilities and/or production equipment.
• Authors and updates manufacturing documents for investigations, change control and validation.
• Drives continuous improvement of deviation management processes.

Skills

Deviation Management

Root Cause Analysis

GMP Compliance

Project Management

Technical Support

Viral Vaccines

Manufacturing

Process Validation

Education

B.S. degree in Engineering or Sciences

Job description

Merck is seeking a Senior Specialist, Engineering at the West Point site to lead investigations stemming from manufacturing deviations in live virus vaccine operations. The role focuses on root-cause analysis, corrective actions, and robust documentation, with cross-functional collaboration across safety, quality, automation, and production teams.

You will design experiments, support shop-floor troubleshooting, and drive continuous improvement within Deviation Management, while maintaining GMP