CSV Specialist

Position Overview

We are seeking an experienced Computer System Validation (CSV) Specialist with strong expertise in isolator systems to support validation activities within a regulated life sciences environment. The successful candidate will play a key role in ensuring that automated systems associated with isolators are validated in compliance with regulatory expectations and industry best practices, using a paper‑based validation approach.

Key Responsibilities

• Lead and execute CSV activities for isolator systems and associated software platforms
• Develop and review validation deliverables, including:
  • Validation Plans / Validation Master Plans (VMP)
  • User Requirements Specifications (URS)
  • Functional / Design Specifications (FS/DS)
  • Risk Assessments (GAMP 5 aligned)
  • IQ/OQ/PQ protocols and reports
  • Traceability Matrices
• Support system lifecycle validation fro...