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.