Job Description

NuGenesis ELN Validation Engineer

Location: Morrisville, NC
Type of position: Contract
Duration: 12+ months
* Candidates must hold a Green Card or US Citizenship

Provide validation activities for projects involving Waters NuGenesis system (ELN).
  • 8+ years of CSV experience.
  • Prior experience validating / writing test scripts for an ELN - Waters NuGenesis.
  • Experience in FDA regulated environment with good understanding compliance issues as well as cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk-based validation.
  • Conduct computer system validation work, assuring thoroughness of validation planning and making appropriate progress towards timely completion of validation deliverables.
  • Develop validation strategy documents, write user requirements, SOPs, IQ/OQ/PQ, and create validation summary reports.
  • Strong verbal and written communication skills are essential.

Application Instructions

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