Vacancy Description
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...
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