GMP Process Engineer: Pharma/Biotech Manufacturing

Pinnaql, Inc.; Holly Springs (NC); On-site; USD 90,000 - 140,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks an experienced Process Engineer to support regulated pharmaceutical/biotech manufacturing environments.

You will collaborate with Manufacturing, Quality, Validation and Maintenance to drive process performance, equipment improvements, and CAPA-driven enhancements. The ideal candidate brings hands-on engineering, strong problem-solving, and the ability to manage activities from problem identification through implementation and

Qualifications

• Bachelor-level engineering degree in a related discipline with hands-on experience in a regulated manufacturing setting.
• Experience supporting process and equipment-related issues in GMP environments.
• Familiarity with change control, deviations, CAPA, 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.

Skills

Troubleshooting

Root cause analysis

Process optimization

Technical writing

Cross-functional collaboration

GMP compliance

Education

B.S. in Chemical Engineering

B.S. in Mechanical Engineering

B.S. in Industrial Engineering

B.S. in Bioengineering

Tools

Automation systems

Process control software

Job description

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks an experienced Process Engineer to support regulated pharmaceutical/biotech manufacturing environments.

You will collaborate with Manufacturing, Quality, Validation and Maintenance to drive process performance, equipment improvements, and CAPA-driven enhancements. The ideal candidate brings hands-on engineering, strong problem-solving, and the ability to manage activities from problem identification through implementation and