Senior Computer System Validation (CSV) Analyst

Senior Computer System Validation (CSV) Analyst

Req ID :

Experience Required : 12+ Years

Industry : Pharmaceutical / Biotechnology / Medical Devices (FDA-Regulated)

Job Summary

We are seeking a highly experienced and detail‑oriented Senior Computer System Validation (CSV) Analyst to lead validation efforts for GxP‑regulated computerized systems across IT, laboratory, and manufacturing environments. This role is responsible for ensuring systems operate accurately, reliably, and in full compliance with global regulatory requirements including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.

The ideal candidate will bring deep expertise in risk‑based validation, lifecycle management, audit readiness, and regulatory compliance, while also providing strategic guidance and mentorship to cross‑functional teams.

Key Responsibilities

• Lead the development, review, and approval of Validation Plans...