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Role: Computer System Validation Engineer (CSV)
Location: Puerto Rico, TX
Duration: contract (w2)
MUST - CSV, Validation, Testing, Reports, Test, data validation, GAMP, CFR
We are seeking a skilled Computer System Validation Engineer to lead the full lifecycle validation of computerized systems, ensuring compliance with GxP regulations and CSV guidelines.
Key Responsibilities:
• Develop and execute validation deliverables, including validation plans, risk assessments, and traceability matrices.
• Author and review validation documents such as User Requirements, Functional Specifications, IQ, OQ, PQ, SOPs, and Validation Reports.
• Perform test planning, strategy development, execution, and reporting.
• Manage defect logging and resolution to closure.
• Ensure system compliance with GAMP, CFR, and other applicable regulations.
• Collaborate with stakeholders to provide validation strategies for system changes.
• Conduct impact assessments and manage change controls for computerized systems.
Essential Skills:
• Expertise in full lifecycle validation and CSV documentation.
• Proficiency in compliance analysis, risk assessment, and traceability.
• Strong understanding of GxP regulations and computer system validation guidance.
• Experience in test planning, execution, and reporting.
Desirable Skills:
• Knowledge of medical device regulations and GAMP guidelines.
• Ability to manage changes and deviations effectively.
• Excellent collaboration and communication skills.
Competency:
• EIS: Medical Device & Regulations
