Senior CSV Validation Engineer

About the role

This senior, hands‑on position focuses on computerized system validation (CSV) for complex technology platforms used in pharmaceutical and other GxP‑regulated environments. Based in Saudi Arabia, you will lead risk‑based validation across cloud applications, edge devices, scientific instruments, APIs, databases and enterprise integrations, ensuring systems are fit for intended use and inspection‑ready.

Key responsibilities

• Develop and execute risk‑based validation strategies for new systems, features, integrations and infrastructure changes.
• Create and maintain CSV deliverables such as validation plans, requirements, functional specifications, risk assessments, test protocols, IQ/OQ/PQ documentation and traceability matrices.
• Translate regulatory and business requirements into clear, testable acceptance criteria and maintain full traceability of requirements, risks, tests and evidence.
• Validate complex ecosystems spanning browser applications, cloud services, APIs, databases, edge devices, scientific instruments and integrations with LIMS, MES, ELN and QMS.
• Assess data flows, transformations, mappings, synchronization, recovery behavior and failure scenarios to protect data integrity.
• Evaluate systems against FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, ALCOA+ principles and related regulatory expectations.
• Perform impact assessments for software releases, configuration changes, security events, deviations and CAPAs.

Required profile

• Senior‑level experience in computerized system validation within GxP‑regulated environments.
• Strong understanding of risk‑based validation methodologies and regulatory frameworks.
• Proven ability to work collaboratively with engineering, quality, operations, suppliers and customers across the system lifecycle.
• Excellent analytical skills to investigate architectures, data flows and system behavior.

Required skills

• Computerized System Validation (CSV) and risk‑based validation
• Cloud applications, APIs and database testing
• Edge devices and scientific instrument integration
• LIMS, MES, ELN and QMS integration knowledge
• Regulatory standards: FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, ALCOA+ data‑integrity principles
• Creation of IQ/OQ/PQ documentation, test protocols and traceability matrices