Demo

Validation Engineer

Fladger Associates
Santa Monica, CA Full Time
POSTED ON 2/9/2025
AVAILABLE BEFORE 5/9/2025

Responsibilities :

  • Excellent employment opportunity for a Validation Engineer – III in the Santa Monica, CA area.
  • Monday to Friday, 8am-5pm Pacific
  • 100% on-site (Mon-Fri)? Onsite at least 3 days a week (Hybrid)
  • Responsible for developing CSV related documents in support of :
  • 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 tasks :
  • Audit trail review
  • Draft admin sop for each equipment system
  • Draft data integrity validation plan
  • Perform risk assessment for audit trail review requirement
  • Configure user access per part 11
  • Act as system admin for all equipment system

Experience :

  • Previous work experience with similar medium / large Pharmaceutical required.
  • 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)
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