CSV Engineer

Summary 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 systems • Support validation activities for ERP Master Data Governance processes, ensuring data accuracy, integrity, and compliance • Perform validation of Data Lake platforms and associated system interfaces, including data ingestion, transformation, and reporting layers • Collaborate with cross-functional teams (IT, QA, Business, Data Engineering) to define validation scope, risk assessments, and acceptance criteria • Ensure compliance with GxP, 21 CFR Part 11, and data integrity requirements throughout the system lifecycle • Support deviation investigations, CAPAs, and change control activities related to validated systems • Maintain validation documentation including Validation Plans, Risk Assessments, Traceability Matrices, and Summary Reports Education & Experience • Bachelor's degree in Computer Science, Engineering, Life Sciences, or related discipline • 5+ years of Computer System Validation (CSV) experience in pharmaceutical or life sciences environments • Strong experience with test script authoring and execution for GxP systems • Experience 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 plus • Experience with validation management tools such as Val Genesis is a plus • Strong understanding of GxP, 21 CFR Part 11, and data integrity principles • Ability to work independently and manage multiple validation activities with minimal oversight