CSV Documentation Specialist / Computer System Validation (CSV) Specialist
Job Summary
We are seeking a detail-oriented and technically strong Computer System Validation (CSV) Documentation Specialist to support validation, compliance, and quality assurance activities for healthcare and software systems. The ideal candidate will have hands-on experience in preparing and managing validation documentation including SRS, FRA, Validation Plans, IQ/OQ/PQ protocols, Traceability Matrices, SDCS (System Design & Configuration Specifications), Change Controls, and validation reports.
The candidate should possess strong knowledge of the Software Development Life Cycle (SDLC), quality management systems, and regulated validation environments. Excellent spoken and written communication skills are essential, along with the ability to collaborate effectively with QA, Engineering, Product, Compliance, and Business teams.
Experience with QMS platforms such as MasterControl, Arena, or s...