What are the responsibilities and job description for the Sr. Validation Engineer position at Fladger Associates?
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)
