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Validation/Commissioning Engineer

Job

Insight Global

Fuquay-Varina, NC (In Person)

Full-Time

Posted 1 week ago (Updated 2 days ago) • Actively hiring

Expires 7/21/2026

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Job Description

Validation/Commissioning Engineer at Insight Global Validation/Commissioning Engineer at Insight Global in Fuquay Varina, North Carolina Posted in 7 days ago.
Type:
full-time
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 Must haves: 2-5 years of experience with hands on commissioning & execution, not just documentation Experience a blend of the below equipment Large stainless-steel tanks (100L-12,000L) UF skids and chromatography systems (more complex systems) Pumps, heat exchangers, and related downstream equipment Will take upstream or downstream experience Need at least 1 full year with large scale operations biotech experience - pumps, bioreactors, big stainless-steel equipment
Includes:
Commissioning / first-time startup activities Shakedown testing & startup testing, troubleshooting during execution Strong experience with protocol execution - IQ/OQ/ PQ execution Drafting validation protocols Review & approval with quality & engineering Executing those protocols in the field Completing post approval documentation
Pluses:
Greenfield experience Expereince with Kneat