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⏰ Full-time

CSV Engineer

Coalesce Management Consulting
Location 📍 singapore, Singapore
Posted 📅 June 03, 2026
Work Type ⏰ Full-time

Position Overview

We are seeking a Computer System Validation (CSV) Engineer that is able to join our pharmaceutical operations team Mid May 2026 .

Key Responsibilities
  • Manage the full CSV lifecycle (planning, design, testing, execution, reporting, and closure) for standalone systems such as LIMS, chromatography data systems, environmental monitoring software, and equipment control systems.
  • Develop and execute validation documentation including User Requirement Specifications (URS), Functional Specifications (FS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Perform risk assessments to determine validation scope and ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11 , and other relevant guidelines.
  • Collaborate with QA, IT, and system owners to ensure proper change management, deviation handling, and system ...

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Job Details

Employment Type
Full-time
📊
Category
Other-General
🏠
Work Arrangement
On-site
📍
Location
singapore, Singapore