CSV Validation Engineer

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a CSV Validation Engineer based in Canada.

This is a senior, hands-on validation role supporting complex technology platforms used in pharmaceutical and other GxP-regulated environments.

• 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