CSV Validation Engineer

Position Overview

This role is a senior, hands-on validation position based in the United Arab Emirates, focusing on computerized system validation (CSV) for complex technology ecosystems in pharmaceutical and other GxP-regulated sectors. The position involves leading risk-based validation activities across diverse systems such as cloud applications, edge devices, scientific instruments, APIs, databases, and enterprise integrations, ensuring systems are compliant, secure, reliable, and supported by thorough documentation ready for inspection.

Key Responsibilities

• Design and implement risk-based validation strategies for new systems, product features, infrastructure changes, releases, and customer implementations, aligning scope with intended use, complexity, data integrity risks, and regulatory standards.
• Develop and maintain comprehensive CSV documentation including validation plans, requirements, specifications, risk assessments, test protocols, IQ/OQ/PQ documentation, traceability matrices, deviation logs, and summary reports.
• Convert regulatory and business requirements into clear, objective, and testable acceptance criteria while maintaining complete traceability of requirements, risks, tests, defects, and evidence.
• Validate complex systems spanning browser-based apps, cloud platforms, APIs, databases, edge computing devices, scientific instruments, and their integrations with regulated enterprise systems like LIMS, MES, ELN, and QMS.
• Assess data processing including flows, transformations, mappings, unit conversions, synchronization, and error handling to prevent data loss, duplication, corruption, or misattribution.
• Evaluate system compliance against regulations such as FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, and ALCOA+ data integrity principles.
• Validate controls related to electronic records and signatures, audit trails, access and identity management, security, timestamps, data retention, archival, backups, recovery, and availability.
• Conduct impact assessments for software releases, configuration changes, infrastructure updates, bug fixes, security events, deviations, CAPAs, and integration modifications, to define regression and validation scopes.
• Maintain validated systems by supporting periodic reviews, controlled retirement, migration, archival, decommissioning, and resolving outstanding validation issues.
• Collaborate with Engineering, Product, Quality, Operations, suppliers, and customers to review technical and engineering evidence, streamline testing, and manage GxP risks.
• Prepare validation packages for quality reviews, audits, supplier assessments, and regulatory inspections, articulating validation approaches, risk justifications, controls, and evidence clearly.
• Investigate anomalies and deviations, prioritizing real product risks over low-value documentation concerns and supporting corrective and preventive measures.
• Contribute to establishing standardized validation templates, processes, and practical, delivery-focused validation methods aligned with modern Computer Software Assurance principles in an evolving organization.

Qualifications and Experience

• Over 10 years of hands-on experience in computerized system validation within pharmaceutical, biotech, life sciences, or related GxP environments with full ownership of CSV deliverables.
• In-depth knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, and ALCOA+ data integrity standards.
• Proven ability to apply risk-based validation and Computer Software Assurance methods to complex systems.
• Experience in authoring user requirements, risk assessments, validation plans, test protocols, traceability matrices, deviation management, summary reports, and IQ/OQ/PQ documentation where applicable.
• Background in validating configurable software, SaaS applications, cloud platforms, laboratory software, manufacturing systems, or integrated technology frameworks.
• Strong understanding of electronic records management, electronic signatures, audit trails, security, access control, backup/recovery, retention, archival, and data migration processes.
• Ability to analyze technical documentation, system architectures, data flows, API specs, engineering test evidence, and software change impacts effectively.
• Excellent analytical and troubleshooting skills to investigate discrepancies and understand complex system behaviors.
• Strong technical writing capabilities focused on clear, defensible, objective, and inspection-ready documentation.
• Capacity to independently manage multiple validation projects with efficient prioritization and minimal supervision.
• Excellent communication and collaboration skills to work with multi-disciplinary teams remotely.
• Experience with cloud software, edge computing, IoT devices, and scientific instruments preferred.
• Knowledge of validations related to LIMS, MES, ELN, QMS, or similar enterprise integrations is advantageous.
• Familiarity with RESTful APIs, relational databases, SQL, MQTT, asynchronous messaging, data transformations, field mappings, unit conversions, and multi-vendor data formats is beneficial.
• Experience in Agile development environments and utilizing automated engineering tests as validation evidence is a plus.
• Understanding of cloud infrastructure qualification, supplier audits, customer-specific deployments, deviation handling, CAPAs, change control, document control, and periodic review mechanisms is desirable.
• Exposure to Japanese PMDA regulations or other Asia-Pacific authorities and experience in customer audits or regulatory inspections is an added advantage.

Benefits

• Senior-level role offering significant responsibility over CSV and regulated technology platforms.
• Hands-on involvement with complex ecosystems combining cloud, edge, laboratory, manufacturing, APIs, and scientific instruments.
• Opportunity to shape and improve validation processes within a growing organization.
• Collaboration with diverse, cross-functional teams including technical, product, quality, and customer-facing stakeholders.
• Remote working with autonomy and responsibility.
• Application of modern risk-based validation and Computer Software Assurance strategies.
• Professional growth opportunities through exposure to new technologies, regulatory frameworks, and GxP use cases.
• Direct contribution to the compliance, reliability, and audit readiness of critical systems.