CSV Engineer

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
• Validate 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