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Computer System Validation Engineer

ACL Digital
Santa Monica, CA Temporary
POSTED ON 2/8/2025
AVAILABLE BEFORE 5/6/2025

Job Title : Validation Engineer

Location : Santa Monica, CA

Duration : 10 Months contract

M-F, 8-5 Pacific

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

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

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 Val 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

Primary Job Duties / Responsibilities?

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)

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