NuGenesis ELN Validation Lead - REMOTE

Location: Remote, Anywhere
Date Posted: 07-27-2018
We are seeking a Lead Validation Manager to oversee and provide leadership on a ELN NuGensis deployment to a site for a top pharmaceutical company. We need a CSV lead to help manage and guide the Vendor and Internal teams as well as fill in the gaps with some of the CSV documentation. 

The right person for this will have ELN validation management / lead experience (preferably with ELN NuGenesis or LabWare ELN). *Will be able to work remotely with occasional travel as needed.
Location: Remote with occasional travel
Type of position: Contract (C2C, 1099 or W-2)
Duration:11+ months

 Provide validation management activities for projects involving Waters NuGenesis system (ELN) deployment. 
  • 10+ years of CSV experience.
  • Must have Validation / Lead Management experience with ELN Deployment
  • Prior management/lead experience with managing 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.
  • Ability to lead and pull together vendors and internal resources to deploy ELN to sites.
  • Strong verbal and written communication skills are essential.
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