Validation Engineer III in Santa Monica, CA

M-F, 8-5 Pacific

100% on-site (Mon-Fri)? Onsite at least 3 days a week (Hybrid)

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

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 Val Lead -

• Audit trail review
• Draft admin SOPs 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

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