Senior Process Engineer — GMP Manufacturing & CI

Veg Group; Cary (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

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

You will work with Engineering, Manufacturing, Quality, Validation, and Maintenance to improve process performance and lead troubleshooting and improvement initiatives. The ideal candidate has 5+ years of process/manufacturing engineering experience in pharma/biotech, strong GMP and documentation

Qualifications

• Bachelor's degree in Chemical, Mechanical, Industrial, or Bioengineering or related discipline.
• 5+ years of process/manufacturing engineering experience in pharma/biotech or regulated manufacturing.
• Strong GMP, change control, deviations, CAPA, and engineering documentation experience.
• Ability to analyze technical data and translate findings into practical solutions.
• Excellent technical writing and cross-functional collaboration skills.

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.
• Support equipment and process design reviews, technical evaluations, and implementation activities.
• 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.
• Coordinate activities with vendors, contractors, and equipment suppliers when required.
• Ensure engineering activities are performed in accordance with GMP requirements, engineering standards, procedures, and safety expectations.
• Maintain clear documentation and communicate project status, technical issues, risks, and recommendations to stakeholders.
• Support continuous improvement and standardization initiatives within the Engineering organization.

Skills

Process engineering

GMP knowledge

Documentation

Root cause analysis

Cross-functional collaboration

Education

Bachelor's degree (Chemical, Mechanical, Industrial, Bioengineering)

Tools

Automation & process control systems

Job description

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

You will work with Engineering, Manufacturing, Quality, Validation, and Maintenance to improve process performance and lead troubleshooting and improvement initiatives. The ideal candidate has 5+ years of process/manufacturing engineering experience in pharma/biotech, strong GMP and documentation