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CSV Validation Engineer

Infotree Global Solutions
Santa Monica, CA Full Time
POSTED ON 2/8/2025
AVAILABLE BEFORE 5/8/2025

Key Responsibilities :

Responsible for creating CSV (Computer System Validation) documentation to support the following software upgrades and system validations :

  • ELLA Immunoassay Explorer & Runner software upgrade
  • MSD Methodical Mind / Discovery Workbench analysis software upgrade
  • QX Manager software upgrade
  • ViCell Blue Analyzer software upgrade
  • Nanodrop software upgrade
  • BD LSRFortessa software upgrade
  • FlowJo analysis software upgrade
  • Sony Spectral Cell Analyzer system validation (new)
  • Olink Signature Q100 system validation (new)
  • Excel macro validation (new)

Additional Responsibilities for Validation Lead :

  • Conduct audit trail reviews
  • Develop administrative SOPs for each equipment system
  • Create data integrity validation plans
  • Perform risk assessments for audit trail review requirements
  • Configure user access in compliance with Part 11 regulations
  • Serve as the system administrator for all equipment systems

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