CSV Validation Engineer

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. Your work will help ensure regulated systems are fit for intended use, secure, reliable, and supported by complete, inspection-ready evidence. You will collaborate closely with Engineering, Product, Quality, Operations, suppliers, and customers across the full system lifecycle. The role combines regulatory expertise with technical investigation, requiring you to understand architectures, data flows, integrations, and system behavior. You will also help mature validation practices by introducing practical structure, improving traceability, and leveraging modern engineering evidence. This is an opportunity to make a direct impact in a growing environment where validation is treated as a critical engineering discipline rather than a documentation exercise. Accountabilities

• Develop and execute risk-based validation strategies for new systems, product features, integrations, infrastructure changes, releases, and customer implementations, defining appropriate scope according to intended use, system complexity, data-integrity risks, and regulatory requirements.
• Create, maintain, and execute comprehensive CSV deliverables, including validation plans, requirements, functional and configuration specifications, risk assessments, test protocols, IQ/OQ/PQ documentation where applicable, traceability matrices, deviation records, and validation summary reports.
• Translate regulatory and business requirements into clear, objective, testable acceptance criteria and ensure requirements, risks, tests, defects, and evidence remain fully traceable.
• Validate complex technology ecosystems spanning browser applications, cloud services, APIs, databases, edge devices, scientific instruments, and integrations with LIMS, MES, ELN, QMS, and other regulated systems.
• Assess and test data flows, transformations, mappings, unit conversions, synchronization, recovery behavior, and failure scenarios to ensure data is not lost, duplicated, corrupted, or incorrectly attributed.
• Evaluate systems against FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, ALCOA+ data-integrity principles, and other applicable regulatory expectations.
• Validate controls covering electronic records and signatures, audit trails, identity and access management, security, timestamps, retention, archival, backup, recovery, availability, and data migration.
• Perform validation impact assessments for software releases, configuration changes, infrastructure updates, bug fixes, security events, deviations, CAPAs, and integration changes, determining appropriate regression and validation scope.
• Maintain systems in a validated state by supporting periodic reviews, controlled retirement, migration, archival, decommissioning, and resolution of open validation discrepancies.
• Partner with Engineering, Product, Quality, Operations, suppliers, and customer teams to review technical documentation and engineering evidence, avoid unnecessary testing duplication, and ensure GxP risks remain appropriately covered.
• Prepare validation packages for Quality review, customer audits, supplier assessments, and regulatory inspections, clearly explaining validation strategies, risk decisions, controls, and test evidence.
• Investigate unexpected results and discrepancies, distinguish meaningful product risks from low-value documentation issues, and support corrective and preventive actions.
• Help establish consistent validation templates, processes, and practices within a growing organization while remaining practical, delivery-focused, and aligned with modern Computer Software Assurance principles.

• 10+ years of computerized system validation experience within pharmaceutical, biotechnology, life sciences, or another GxP-regulated environment, with proven ownership of end-to-end CSV activities.
• Strong practical knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, and ALCOA+ data-integrity principles.
• Demonstrated experience applying risk-based validation and Computer Software Assurance approaches to complex systems.
• Hands-on experience developing user requirements, risk assessments, validation plans, protocols, traceability matrices, deviations, summary reports, and IQ/OQ/PQ documentation where applicable.
• Experience validating configurable software, SaaS applications, cloud platforms, laboratory systems, manufacturing systems, or integrated technology environments.
• Strong understanding of electronic records, electronic signatures, audit trails, access controls, security, backup and recovery, retention, archival, and data migration.
• Ability to understand and review technical documentation, system architectures, data flows, API specifications, engineering test evidence, and software change impacts.
• Strong analytical and troubleshooting skills, with the ability to investigate discrepancies and understand how complex technical systems behave.
• Excellent technical writing and documentation skills, with a focus on producing clear, defensible, objective, and inspection-ready evidence.
• Ability to manage multiple validation workstreams independently, prioritize competing deliverables, and operate effectively with limited supervision.
• Strong communication and collaboration skills, with the ability to work effectively across Engineering, Product, Quality, Operations, suppliers, and customer stakeholders in a remote environment.
• Experience with cloud software, hardware, edge computing, IoT devices, and scientific instruments is strongly preferred.
• Experience validating LIMS, MES, ELN, QMS, or similar enterprise integrations is an advantage.
• Familiarity with REST APIs, relational databases, SQL, MQTT, asynchronous messaging, data transformations, field mappings, unit conversions, and multi-vendor data formats is beneficial.
• Experience working within Agile software development environments and leveraging automated engineering tests as validation evidence is a plus.
• Familiarity with cloud infrastructure qualification, supplier assessments, customer-specific deployments, deviation management, CAPA, change control, document control, and periodic review processes is desirable.

• Exposure to Japanese PMDA expectations or other Asia-Pacific regulatory authorities, as well as customer audits or regulatory inspections, would be an advantage.

• Senior-level opportunity with significant ownership across computerized system validation and regulated technology platforms.
• Hands-on exposure to complex cloud, edge, laboratory, manufacturing, API, and scientific-instrument environments.
• Opportunity to influence and strengthen validation processes within a growing organization.
• Collaboration with cross-functional technical, product, quality, and customer-facing teams.
• Remote-friendly working environment with autonomy and responsibility.
• Opportunity to apply modern risk-based validation and Computer Software Assurance practices.
• Professional growth through exposure to evolving technologies, regulatory requirements, and complex GxP use cases.
• The opportunity to contribute directly to the reliability, compliance, and audit readiness of mission-critical systems.