CSV Engineer

Job-ID32200742Reference26-00496Summary: IT CSV Validation Engineer is responsible for authoring and executing validation test scripts to support regulated systems within a GxP life sciences environment. This role will focus on validating ERP Master Data Governance processes and Data Lake platforms, ensuring compliance with regulatory requirements and data integrity standards.Roles & Responsibilities:Author, review, and execute validation test scripts (IQ/OQ/PQ) for GxP computerized systemsSupport validation activities for ERP Master Data Governance processes, ensuring data accuracy, integrity, and compliancePerform validation of Data Lake platforms and associated system interfaces, including data ingestion, transformation, and reporting layersCollaborate with cross-functional teams (IT, QA, Business, Data Engineering) to define validation scope, risk assessments, and acceptance criteriaEnsure compliance with GxP, 21 CFR Part 11, and data integrity requirements throughout the system lifecycleSupport deviation investigations, CAPAs, and change control activities related to validated systemsMaintain validation documentation including Validation Plans, Risk Assessments, Traceability Matrices, and Summary ReportsEducation & Experience:Bachelor's degree in Computer Science, Engineering, Life Sciences, or related discipline5+ years of Computer System Validation (CSV) experience in pharmaceutical or life sciences environmentsStrong experience with test script authoring and execution for GxP systemsExperience supporting Master Data Governance processes (SAP experience preferred but not required)Experience validating Data Lake environments and system interfaces (Snowflake experience preferred)Familiarity with AI/advanced data platforms is a plusExperience with validation management tools such as Val Genesis is a plusStrong understanding of GxP, 21 CFR Part 11, and data integrity principlesAbility to work independently and manage multiple validation activities with minimal oversight