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Senior Computer System Validation (CSV) Engineer

ClifyXRichardson, TX🇺🇸United States

Quick overview

SeniorityMid Senior
Work modeOn Site
LocationRichardson, TX, United States
SCADA

Job description

Title: Senior Computer System Validation (CSV) Engineer
Location : Richardson, TX (Onsite)
Contract duration: 12+ months Contract

H1B allowed

Must Have Skills:
⦁ Quality Manual and the relevant regulatory requirements
⦁ OT system
⦁ Quality management for IT and OT systems
Detailed Job Description:
⦁ Qualify IT/OT systems per client's Quality Manual.
⦁ Author, execute and review URS, FS, IQ, OQ and test protocols in Kneat.
⦁ Perform test execution, troubleshooting and defect resolution.
⦁ Review supplier deliverables and verify compliance.
⦁ Coordinate with QA, PCM, ITOT teams and suppliers.
⦁ Participate in FAT, SAT, commissioning and startup activities.
⦁ Strong CSV/CQV experience.
⦁ GMP-regulated pharmaceutical manufacturing background.
⦁ GAMP 5, EU GMP Annex 11, 21 CFR Part 11 knowledge.
⦁ Experience with PLC, SCADA, DCS, MES, Historian, and IT/OT systems.
⦁ Hands-on IQ/OQ/PQ execution and FAT/SAT support.
⦁ Experience using Kneat, ValGenesis, Veeva Vault, TrackWise, ServiceNow or similar validation platforms.
Minimum Years of Experience:8 to 10+ years

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