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Validation Engineer - III

Unicon Pharma Inc
CA Temporary
POSTED ON 2/9/2025 CLOSED ON 5/4/2025

What are the responsibilities and job description for the Validation Engineer - III position at Unicon Pharma Inc?

Title : Validation Engineer III

Location : Santa Monica, CA

Duration : 10 Months Contract

Work Schedule : M-F, 8-5 Pacific & Onsite at least 3 days a week (Hybrid)

Job Description :

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 for Validation Lead :

  • 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

    • Other useful info suppliers should know to understand the "right fit" for this role : Previous work experience with similar medium / large pharma.

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