CSV Engineer

17 hours ago


Gurugram, India ZEN Cloud Systems Private Limited Full time

Computer System Validation (CSV) Engineer

Role: CSV Engineer
Location: Gurugram
Experience: 2–5 Years

Key Responsibilities:

  • Develop & execute validation strategies/plans for computerized systems.
  • Prepare validation docs: URS, FS, Risk Assessments, VP, IQ/OQ/PQ, Traceability Matrix.
  • Ensure compliance with FDA, EMA, GAMP 5, 21 CFR Part 11.
  • Validate systems (LIMS, MES, ERP, QMS, SCADA, PLCs, custom apps).
  • Perform change control, impact assessments & data integrity compliance.
  • Collaborate with IT, QA, Manufacturing; provide CSV training.

Requirements:

  • Bachelor's in Engineering/CS/Life Sciences.
  • 2–5 yrs CSV experience in pharma/biotech/medical devices.
  • Knowledge: GAMP 5, SDLC, Part 11, Annex 11.
  • Strong documentation & project management.
  • Tools: MS Office, ValGenesis/MasterControl (plus).
  • CSV/GxP certifications preferred.

Job Type: Full-time

Work Location: In person



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