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Validation Engineer

Job

Insight Global

Fuquay-Varina, NC (In Person)

Full-Time

Posted 1 week ago (Updated 14 hours ago) • Actively hiring

Expires 7/22/2026

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Job Description

Validation Engineer at Insight Global Validation Engineer at Insight Global in Fuquay Varina, North Carolina Posted in 10 days ago.
Type:
full-time
Job Description:
Job Description:
Insight Global is seeking a team of Validation / Commissioning Engineers to support validation and startup activities within its biologics manufacturing facility in Raleigh-Durham. This role is heavily focused on validation execution, protocol development, and hands-on commissioning activities within a fast-paced GMP environment. The team is looking for engineers who are comfortable working both at a desk and in the field, with a strong emphasis on equipment troubleshooting, startup support, and practical problem-solving.
Responsibilities:
Author and develop validation protocols using standardized templates (IQ/OQ/PQ) Drive protocols through cross-functional review and approval with Engineering and Quality Execute protocols in the field, including: System walkdowns, Startup testing and shake-down activities, Troubleshooting equipment issues during execution, Complete post-execution documentation, deviations, and validation reports Support commissioning activities including: First-time equipment startup, Equipment stand-up and readiness Partner with Engineering, Quality, Automation, and Operations to ensure systems meet GMP and design requirements Utilize CMMS/work orders to support equipment startup and commissioning activities Maintain strong documentation practices aligned with GMP standards