Senior Validation Engineer

Job TitleLead/Support a Veeva LIMS implementation and the validation activities throughout the system lifecycle, from requirements and design through testing, deployment, and validation closeoutDevelop and/or review validation deliverables, including URS, risk assessments, validation plans, test scripts, traceability matrices, validation summary reports, and SOPsPartner with Quality, Laboratory, IT, Business Process Owners, and system stakeholders to define requirements and ensure the LIMS meets business and regulatory needsSupport Veeva LIMS configuration, functional testing, integration testing, user acceptance testing, and defect resolutionApply risk-based CSV/CSA principles and applicable GxP requirements to ensure the validated state of the system is maintainedSupport data migration, interfaces, integrations, and related systems as part of the LIMS implementationParticipate in system change control, deviations, CAPAs, periodic reviews, and other lifecycle activities following implementationProvide technical and validation expertise during implementation meetings, workshops, testing activities, and issue resolutionEnsure validation activities comply with applicable regulatory expectations, company procedures, and industry practices such as GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principlesSupport inspection and audit readiness by ensuring complete, accurate, and traceable validation documentationBachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical discipline5+ years of experience in computerized system validation, quality, or validation engineering within pharmaceutical, biotechnology, or other GxP-regulated environmentsDemonstrated experience with Veeva LIMS implementation, validation, or lifecycle managementStrong understanding of CSV/CSA methodologies, GxP requirements, risk-based validation, and data integrityExperience developing and executing validation/testing documentation, including requirements, risk assessments, test protocols/scripts, traceability, and validation reportsStrong understanding of 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable data integrity principlesStrong project management, organizational, communication, and problem-solving skills