CSV Project Engineer

IDEA Solutions is seeking a CSV Project Engineer to support computer system validation activities within regulated environments. The ideal candidate will have experience with CSV documentation, regulatory requirements, and validation life-cycle activities. Responsibilities: * Develop, review, and execute computer system validation protocols and documentation. * Prepare validation plans, risk assessments, test scripts, traceability matrices, and summary reports. * Support system implementation, upgrades, changes, and periodic reviews. * Ensure compliance with GxP, GAMP 5, FDA 21 CFR Part 11, and applicable regulatory requirements. * Identify and document deviations and support corrective actions. * Collaborate with Quality, Engineering, IT, and other project stakeholders. * Maintain accurate and complete validation records. * Support validation activities using Kneat. Requirements: * Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field. * Minimum of 2–3 years of experience in Computer System Validation. * Experience working in pharmaceutical, biotechnology, medical-device, or other regulated environments. * Knowledge of GxP, GAMP 5, and FDA 21 CFR Part 11. * Basic knowledge of the Kneat platform. * Strong written and verbal communication skills in English and Spanish. * Strong organizational, analytical, and documentation skills. * Ability to work independently and collaborate with multidisciplinary teams. Job Details: * Full-time position * On-site in San Juan, Puerto Rico * Annual salary range: $67,000–$85,000, depending on qualifications and experience Benefits: * Health insurance * 401(k) retirement plan Tipo de puesto: Tiempo completo Beneficios: * * Lugar de trabajo: Híbrido en San Juan, PR 00907