ClifyX
ClifyX

Senior Computer System Validation (CSV) Engineer

Richardson, TX, US • Posted 12 hours ago • Updated 12 hours ago
Contract Corp To Corp
Contract W2
12 Months
Occasional Travel Required
On-site
Depends on Experience
Fitment

Dice Job Match Score™

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Job Details

Skills

  • OT system
  • URS
  • FS
  • IQ

Summary

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 

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: mategr
  • Position Id: Abd 7
  • Posted 12 hours ago
Contact the job poster
Tarique Shaikh

Tarique Shaikh

Recruiter @ ClifyX

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