GMP Process Engineer — Troubleshooting & Process Optimization

Pinnaql, Inc.; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks an experienced Process Engineer to provide technical engineering support in a regulated pharmaceutical/biotechnology manufacturing environment.

You will collaborate with Engineering, Manufacturing, Quality, Validation, Maintenance, and other teams to support process performance, equipment and system improvements, troubleshooting, capital projects, and continuous improvement initiatives.

Qualifications

• Bachelor’s degree in Chemical Engineering or related engineering discipline.
• 5+ years of experience in process/manufacturing engineering in pharma/biotech or regulated manufacturing.
• Strong understanding of GMP, change control, deviations, CAPA, and engineering documentation practices.
• Experience supporting equipment modifications, process improvements, or capital projects.
• Ability to analyze technical data and translate findings into engineering solutions.

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.

Skills

GMP compliance

Process engineering

Root cause analysis

Capital projects

Documentation

Cross-functional collaboration

Education

Bachelor’s degree in Chemical Engineering

Tools

Automation and process control systems

Job description

Validation & Engineering Group, Inc. seeks an experienced Process Engineer to provide technical engineering support in a regulated pharmaceutical/biotechnology manufacturing environment.

You will collaborate with Engineering, Manufacturing, Quality, Validation, Maintenance, and other teams to support process performance, equipment and system improvements, troubleshooting, capital projects, and continuous improvement initiatives.