Computer System Validation Specialist
Alimentiv
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.
#J-18808-LjbffrVacancy posted 1 day ago
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