Computer System Validation Senior Analyst
Hybrid · Heredia, Heredia Province, Costa Rica
Job Summary
Lead and manage the FDA Computer System Validation (CSV) lifecycle end-to-end (planning, execution, documentation, approvals) for validated systems in development, manufacturing, and distribution of FDA-regulated products. Develop, review, and maintain CSV deliverables (validation plans, protocols, risk assessments, traceability matrices, final reports); ensure compliance with FDA regulations (e.g., 21 CFR Part 11/820) and GAMP standards; collaborate with business stakeholders, IT, vendors, Quality, and Compliance to define validation requirements and strategies. Conduct risk assessments and impact analyses to determine critical system functions and appropriate validation approaches. Design and execute validation testing activities (IQ, OQ, PQ, UAT) to meet business and regulatory requirements. Provide oversight, guidance, training, and subject-matter expertise on CSV best practices; drive continuous improvement, support audits/inspections, and resolve deviations and compliance issues. Travel up to 20%. Work Flexibility: Hybrid; Remote – Role allows majority to 100% time from alternate workplace; role may require travel and working within country of job requisition location. Locations: Costa Rica (Heredia San Antonio Business Park), Costa Rica.
Required Qualifications
- Bachelor's degree in Computer Science, Engineering, or a related field
- Minimum of 3 year’s experience in FDA-regulated industries, with focus on computer system validation
- Thorough understanding of FDA regulations and guidelines related to CSV, including 21 CFR Part 11, 21 CFR Part 820, and GAMP
- Proven experience leading and managing CSV activities for complex computer systems in a regulated environment
- Excellent knowledge of CSV methodologies, validation protocols, risk management, and change control processes
- Strong understanding of SDLC methodologies (agile and waterfall)
- Experience with systems like LIMS, EDC, MES
- Strong project management and communication skills
- Travel Percentage: 20%
- Remote work options: Hybrid/Remote potential within country
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.