CSV Engineer
Katalyst HealthCares & Life Sciences
CSV Validation Engineer
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 and responsibilities include:
- 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 and 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
Vacancy posted 4 days ago
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