CSV Validation Engineer

Role Overview

This opportunity is with a partner company seeking a senior CSV Validation Engineer based in Saudi Arabia. The position involves a hands-on role in validation within complex technology platforms used in pharmaceutical and other GxP-regulated environments.

You will be responsible for leading risk-based computerized system validation across diverse systems including cloud applications, edge devices, scientific instruments, APIs, databases, and enterprise integrations.

Your contributions will ensure that regulated systems are fit for their intended uses, secure, reliable, and supported by comprehensive, inspection-ready documentation.

Collaboration will be essential with teams across Engineering, Product, Quality, Operations, suppliers, and customers throughout the entire system lifecycle.

Key Responsibilities

• Develop and implement risk-based validation strategies for new systems, features, infrastructure modifications, releases, and client implementations tailored to system complexity and regulatory guidelines.
• Create and maintain validation documentation packages including plans, requirements, specifications, risk assessments, test protocols, IQ/OQ/PQ documentation where applicable, traceability matrices, deviation logs, and summary reports.
• Translate regulatory and business needs into precise, measurable acceptance criteria ensuring full traceability between requirements, testing, risks, defects, and evidence.
• Validate comprehensive technology ecosystems encompassing browser-based apps, cloud services, APIs, databases, edge computing devices, scientific instruments, and integrations with regulated lab and manufacturing systems.
• Thoroughly test and evaluate data handling including flows, transformations, mappings, synchronization, error recovery, and failure management to prevent data loss, duplication, corruption, or misattribution.
• Assess systems for compliance with FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP guidelines, GAMP 5 standards, ALCOA+ data integrity principles, and other relevant regulations.
• Validate system controls addressing electronic records/signatures, audit trails, identity and access management, security, timestamping, data retention, archival, backup, and recovery procedures.
• Conduct impact analyses related to software updates, configuration changes, infrastructure adjustments, security issues, deviations, CAPAs, and integration alterations to determine appropriate validation efforts.
• Maintain validated system states through periodic reviews, controlled retirement, migrations, archival, decommissioning, and resolution of outstanding discrepancies.
• Work collaboratively with cross-functional teams to review technical materials and engineering evidence, minimize redundant validation testing, and ensure regulatory risks are properly managed.
• Prepare validation documentation packages for quality assurance reviews, client audits, supplier checks, and regulatory inspections, articulating validation approaches, risk rationales, controls, and test outcomes clearly.
• Investigate unexpected results and discrepancies, distinguishing significant product risks from non-critical documentation issues and supporting corrective and preventive actions.
• Promote consistent adoption of validation templates, processes, and best practices aligned with modern Computer Software Assurance principles within the organization.

Candidate Requirements

• Over 10 years of hands-on computerized system validation experience in pharmaceutical, biotechnology, life sciences, or other GxP-regulated sectors with comprehensive end-to-end CSV ownership.
• Strong expertise in FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, and ALCOA+ data integrity principles.
• Proven application of risk-based validation strategies and Computer Software Assurance for complex system environments.
• Experience drafting user requirements, performing risk assessments, developing validation plans and protocols, managing traceability matrices, handling deviations, summary reporting, and IQ/OQ/PQ documentation as applicable.
• Background validating configurable software solutions, SaaS products, cloud platforms, laboratory and manufacturing systems, or integrated technology ecosystems.
• Solid understanding of electronic records/signatures, audit trails, access controls, security frameworks, backup/recovery, data retention, archival, and data migration.
• Competence in interpreting technical documents, system architectures, data flows, API specifications, engineering test results, and software change effects.
• Strong analytical aptitude for troubleshooting system discrepancies and evaluating complex technical behaviors.
• Excellent technical writing abilities focused on clear, defensible, objective, and inspection-ready documentation.
• Ability to independently manage multiple validation projects, prioritize tasks effectively, and perform well with limited oversight.
• Capable communicator and collaborator across diverse functional teams including Engineering, Product, Quality, Operations, and external stakeholders in a remote context.
• Preferred experience with cloud technologies, edge computing, IoT devices, and scientific instrumentation.
• Additional advantage for those with LIMS, MES, ELN, QMS, or similar enterprise integration validation experience.
• Beneficial knowledge of RESTful APIs, relational databases, SQL, MQTT, asynchronous messaging, data transform techniques, field mapping, unit conversions, and handling multi-vendor data formats.
• Familiarity with Agile development methodologies and leveraging automated test suites as validation evidence is a plus.
• Desired knowledge of cloud infrastructure qualification, supplier evaluations, customer-specific deployments, deviation and CAPA management, change and document control, and periodic system review procedures.
• Exposure to regulatory practices from Japanese PMDA or other Asia-Pacific agencies and experience supporting audits or inspections is advantageous.

Benefits

• Senior position with considerable ownership over computerized system validation and regulated technology platforms.
• Direct engagement with complex cloud, edge, laboratory, manufacturing, API, and scientific instrument environments.
• Chance to shape and enhance validation methodologies in a developing organizational setting.
• Interaction with multifunctional teams spanning technical, product, quality, and customer domains.
• A remote-friendly work environment offering autonomy and accountability.
• Application of advanced risk-based validation and Computer Software Assurance concepts.
• Professional development through handling innovative technologies, evolving regulations, and intricate GxP scenarios.
• Opportunity to contribute critically to system reliability, compliance, and readiness for regulatory audits.