A partner company is seeking a senior CSV Validation Engineer based in the United Arab Emirates to lead risk-based computerized system validation across cloud applications, edge devices, scientific instruments, APIs, databases, and enterprise integrations supporting pharmaceutical and other GxP-regulated environments.
About the Role — GxP System Validation Leadership
Core Scope: Risk-based computerized system validation across complex technology ecosystems
Regulatory Standards: FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, ALCOA+
Systems Covered: Cloud platforms, edge devices, LIMS, MES, ELN, QMS, and enterprise integrations
Cross-Functional Collaboration: Engineering, Product, Quality, Operations, suppliers, and customers
Work Format: Remote-friendly working environment with autonomy and responsibility
Career Impact & GxP Validation Opportunity
Total Flexibility: Fully remote role based in the UAE
Technical Ownership: End-to-end ownership of CSV activities across complex, regulated systems
Modern Practice: Apply Computer Software Assurance principles rather than pure documentation exercises
Career Growth: Influence and strengthen validation processes within a growing organization
Position Overview
This is a senior, hands-on validation role supporting complex technology platforms used in pharmaceutical and other GxP-regulated environments. You will lead risk-based computerized system validation across cloud applications, edge devices, scientific instruments, APIs, databases, and enterprise integrations, ensuring regulated systems are fit for intended use, secure, reliable, and supported by complete, inspection-ready evidence.
Why This Role Matters:Â As CSV Validation Engineer, you develop and execute risk-based validation strategies for new systems, integrations, infrastructure changes, and customer implementations, create and maintain comprehensive CSV deliverables including validation plans, risk assessments, and IQ/OQ/PQ documentation, evaluate systems against FDA 21 CFR Part 11, EU GMP Annex 11, GAMP 5, and ALCOA+ data-integrity principles, assess data flows, transformations, and failure scenarios to ensure data integrity across complex integrations, prepare validation packages for Quality review, customer audits, and regulatory inspections, and help mature validation practices by introducing practical structure and leveraging modern Computer Software Assurance principles.
Key Responsibilities
Validation Strategy & Execution
- Develop and execute risk-based validation strategies for new systems, integrations, and releases
- Create, maintain, and execute CSV deliverables including validation plans, risk assessments, and traceability matrices
System & Data Validation
- Validate complex technology ecosystems spanning cloud services, APIs, databases, and LIMS/MES/ELN/QMS integrations
- Assess data flows, transformations, synchronization, and failure scenarios to prevent data loss or corruption
Regulatory Compliance & Audit Readiness
- Evaluate systems against FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, and ALCOA+ principles
- Prepare validation packages for Quality review, customer audits, and regulatory inspections
Cross-Functional Collaboration & Continuous Improvement
- Partner with Engineering, Product, Quality, Operations, suppliers, and customer teams to review technical documentation
- Investigate discrepancies, support CAPAs, and help establish consistent validation templates and processes
Qualifications & Requirements
Experience Requirements
- 10+ years of computerized system validation experience within pharmaceutical, biotechnology, life sciences, or another GxP-regulated environment
- Demonstrated experience applying risk-based validation and Computer Software Assurance approaches
- Hands-on experience developing user requirements, risk assessments, validation plans, and IQ/OQ/PQ documentation
Essential Skills
- Strong practical knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, and ALCOA+
- Strong understanding of electronic records, audit trails, access controls, security, and data migration
- Ability to review technical documentation, system architectures, data flows, and API specifications
- Excellent technical writing skills, producing clear, defensible, inspection-ready evidence
- Ability to manage multiple validation workstreams independently with limited supervision
Preferred Qualifications
- Experience with cloud software, hardware, edge computing, IoT devices, and scientific instruments
- Experience validating LIMS, MES, ELN, QMS, or similar enterprise integrations
- Familiarity with REST APIs, SQL, MQTT, and multi-vendor data formats
- Experience working within Agile software development environments
 About the Opportunity
This position is listed on behalf of a partner company, who manages all applications and next steps. The role offers a senior-level opportunity with significant ownership across computerized system validation and regulated technology platforms, hands-on exposure to complex cloud, edge, laboratory, and manufacturing environments, and the opportunity to influence and strengthen validation processes within a growing organization, all within a remote-friendly working environment with autonomy and responsibility.
Career Excellence: Build senior-level GxP validation expertise across complex, cutting-edge technology ecosystems, in a fully remote role with genuine autonomy and cross-functional influence.
Who Should Apply?
- Senior CSV/Validation Engineers:Â With 10+ years across pharma, biotech, or life sciences
- GAMP 5/Computer Software Assurance Specialists:Â Experienced with modern risk-based validation approaches
- Regulatory Compliance Experts:Â Deep knowledge of FDA 21 CFR Part 11 and EU GMP Annex 11
- Cloud & Edge Technology Validators:Â Comfortable validating complex, integrated technology ecosystems
- Remote-First Technical Professionals:Â Able to manage multiple validation workstreams independently
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