GMP Process Engineer - Pharma Manufacturing Excellence

Pinnaql, Inc.

Cary (NC)

On-site

USD 90,000 - 120,000

Full time

2 days ago
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Job summary

Validation & Engineering Group, Inc. (V&EG) is seeking an experienced Process Engineer to provide regulatory-compliant engineering support in a GMP manufacturing setting.

You will work with cross-functional teams to improve process performance, equipment reliability, and project execution from start to finish. The role emphasizes hands-on technical problem solving, independent activity management, and collaboration with Validation, Manufacturing, Quality, and Maintenance to drive continuous

Qualifications

  • Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, Bioengineering, or a related engineering discipline.
  • 5+ years of process or manufacturing engineering experience in pharmaceutical, biotechnology, medical device, or regulated manufacturing.
  • Strong GMP, change control, deviations, CAPA, and engineering documentation experience.
  • Experience supporting equipment modifications, capital projects, or lifecycle activities.

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 assessments, specifications, protocols, reports, procedures, and change-control docs.

Skills

Process Engineering
Troubleshooting
Root Cause Analysis
Process Optimization
Cross-Functional Collaboration
Technical Documentation
GMP Compliance
CAPA
Capital Projects
CQV Support
Automation & Process Control

Education

Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, Bioengineering, or related engineering discipline

Job description

Validation & Engineering Group, Inc. (V&EG) is seeking an experienced Process Engineer to provide regulatory-compliant engineering support in a GMP manufacturing setting.

You will work with cross-functional teams to improve process performance, equipment reliability, and project execution from start to finish. The role emphasizes hands-on technical problem solving, independent activity management, and collaboration with Validation, Manufacturing, Quality, and Maintenance to drive continuous

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