CSV Validation Engineer

About the role

This senior, hands‑on position is based in the United Arab Emirates and focuses on computerized system validation (CSV) for complex technology platforms used in pharmaceutical and other GxP‑regulated environments. 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, maintain and run comprehensive CSV deliverables such as validation plans, requirements, functional specifications, risk assessments, test protocols, IQ/OQ/PQ documentation, traceability matrices and summary reports.
• Translate regulatory and business requirements into clear, testable acceptance criteria and ensure full traceability of requirements, risks, tests, defects and evidence.
• Validate complex ecosystems spanning browser applications, cloud services, APIs, databases, edge devices, scientific instruments and integrations with LIMS, MES, ELN, QMS and other regulated systems.
• Assess data flows, transformations, mappings, synchronization, recovery behavior and failure scenarios to guarantee data integrity.
• Evaluate systems against FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, ALCOA+ and related regulatory expectations.
• Perform impact assessments for software releases, configuration changes, security events, deviations, CAPAs and integration updates.

Required profile

• Significant experience in computerized system validation within GxP‑regulated environments.
• Strong understanding of risk‑based validation principles and regulatory frameworks (e.g., FDA 21 CFR Part 11, EU GMP Annex 11).
• Ability to work collaboratively with engineering, quality, operations, suppliers and customers throughout the system lifecycle.
• Excellent analytical skills to investigate system behavior, data flows and integration points.

Required skills

• Cloud applications
• APIs
• Databases
• Edge devices
• Scientific instruments
• LIMS
• MES
• ELN
• QMS