What are the responsibilities and job description for the CSV 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)
