CSV Engineer - Computerized Systems Validation | Medical Device Industry

Qualifications

• Bachelor's degree in Engineering, Computer Science, or related field preferred.
• Experience in Computerized Systems Validation (CSV) in FDA-regulated environments.
• Experience in medical device manufacturing highly preferred.
• Familiarity with IQ/OQ/PQ and risk-based validation methodologies.
• Knowledge of FDA 21 CFR Part 11, ISO 13485, and GAMP 5 principles.
• Strong technical writing and analytical skills.
• Bilingual in English and Spanish preferred.

Responsibilities

• Develop, execute, and maintain validation protocols and documentation.
• Prepare and review validation deliverables like URS and risk assessments.
• Support validation of manufacturing, laboratory, and quality systems.
• Ensure compliance with FDA requirements and ISO standards.
• Collaborate with Engineering, Quality Assurance, IT, and Manufacturing teams.
• Support validation testing and discrepancy investigations.
• Maintain accurate and audit-ready validation documentation.

Benefits

• Opportunity to work in a dynamic and regulated industry.
• Collaborative work environment with multidisciplinary teams.
• Potential for professional growth in the medical device sector.