Computer System Validation Specialist

Computer system validation specialists apply GxP compliance and testing expertise at Alimentiv, supporting reliable GCP-regulated systems with IT and Quality teams. As a Computer System Validation Specialist, you will lead validation from planning through execution. The work covers validation documentation, requirements testing, defect management, and change management. You will support compliant solutions across a global CRO focused on gastrointestinal diseases. Key Responsibilities:

Execute computerized system validation under GxP and 21 CFR Part 11 Develop plans, scripts, traceability matrices, and summary reports Coordinate testing with IT, Quality, stakeholders, and vendors Track defects, deviations, incidents, resolutions, and closure documentation Train teams on validation procedures, tools, and documentation standards Requirements:

Bachelor's degree or equivalent education and experience Three to five years of relevant experience Experience validating GCP-regulated systems in regulated industries Understanding of validation, change control, training, and audit readiness Strong communication and cross-functional collaboration skills Bring validation documentation, testing coordination, and regulatory knowledge to strengthen system quality and compliance at Alimentiv.

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