CSV Engineer

Role: CSV EngineerLocation: Remote (India)Contract Type: Long-TermKey Responsibilities: • Develop and execute remediation activities for Computer System Validation (CSV) to assess, plan, and enhance CSV processes and execution in alignment with organizational and regulatory standards. • Develop and execute validation plans for new and existing GxP computer systems and digital solutions. • Lead and support various SDLC and Software Verification & Validation (V&V) activities, including requirements analysis, validation planning and reporting, testing, qualification, and other deliverables required to meet CSV objectives. • Create and maintain validation documentation such as test protocols, reports, and risk/compliance assessments. • Conduct assessments and periodic reviews of validated systems to ensure ongoing compliance with regulatory requirements and internal procedures. • Provide subject matter expertise (SME) in CSV to system owners and users of validated systems. • Collaborate with Quality Assurance teams to support the development and implementation of quality improvement initiatives.Education: Bachelor’s degree or equivalent in Computer Science, Engineering, Life Sciences, Data Science, or a related field (advanced degrees preferred).Experience and Skills Required: • 4–6 years of relevant experience in Computer System Validation (CSV). • Experience in CSV within the medical device, MedTech, or pharmaceutical industry. • Strong understanding of 21 CFR Part 11, EU Annex 11, and other applicable regulatory requirements such as ISO 13485, FDA CSA, and MDSAP.