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CSV Engineer

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Coalesce Management Consulting
πŸ“ singapore, Singapore
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Location singapore
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Posted June 05, 2026
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Commute Local Area
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Job Description

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 sy...

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πŸ“ Location Details

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City
singapore
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Country
Singapore
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Commute
Local Area

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