Pharma Process Engineer — GMP, Troubleshooting & CQV

Veg Group; Holly Springs (NC); On-site; USD 95,000 - 135,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG) seeks an experienced Process Engineer to support manufacturing in a GMP-regulated environment. You will work with Engineering, Manufacturing, Quality, Validation, and Maintenance teams to improve process performance, troubleshoot equipment, and drive capital projects.

The role emphasizes independent management of engineering activities from problem identification to implementation, with strong technical problem-solving and writing skills.

Qualifications

• Experience in process engineering within regulated pharma/biotech/manufacturing environments.
• Strong troubleshooting and root-cause analysis skills in manufacturing processes.
• Experience with GMP/change control/deviations/CAPAs and engineering documentation practices.

Responsibilities

• Provide day-to-day process engineering support to manufacturing and engineering operations.
• Evaluate process performance and identify opportunities to improve reliability, efficiency, capacity, quality, and operational performance.
• Lead or support troubleshooting and root-cause investigations related to manufacturing processes, equipment, and systems.
• Develop and implement engineering solutions to address process and equipment issues.
• Support capital projects, equipment upgrades, system modifications, and process improvement initiatives.
• Develop and review technical documentation including engineering assessments, specifications, protocols, reports, procedures, and change-control documentation.
• Coordinate engineering activities with Manufacturing, Quality, Validation, Automation, Maintenance, and other technical groups.
• Support commissioning, qualification, validation, startup, and turnover activities as required.
• Participate in change controls, deviations, investigations, CAPAs, and risk assessments from an engineering perspective.
• Analyze process and equipment data to identify trends, recurring issues, and improvement opportunities.
• Provide technical recommendations and support the development of corrective and preventive solutions.

Skills

Process engineering

Troubleshooting

Root cause analysis

Technical writing

Documentation

Cross-functional collaboration

Education

Bachelor’s degree in Chemical/Mechanical/Industrial/Bioengineering

Job description

Validation & Engineering Group, Inc. (V&EG) seeks an experienced Process Engineer to support manufacturing in a GMP-regulated environment. You will work with Engineering, Manufacturing, Quality, Validation, and Maintenance teams to improve process performance, troubleshoot equipment, and drive capital projects.

The role emphasizes independent management of engineering activities from problem identification to implementation, with strong technical problem-solving and writing skills.