CSV Validation Engineer - GxP Data Integrity Expert

Katalyst CRO; New Jersey; In loco; USD 120.000 - 150.000; Tempo pieno

Descrizione del lavoro

Katalyst CRO is seeking a CSV Validation Engineer in New Jersey to author and execute validation scripts for GxP systems, focusing on ERP Master Data Governance and Data Lake validation. The role requires strong experience in CSV testing and regulatory compliance, collaborating with IT, QA, and Data Engineering teams.

Responsibilities include IQ/OQ/PQ validation activities, data integrity assurance, and maintenance of validation documentation, with emphasis on adherence to 21 CFR Part 11 and

Competenze

• 5+ years of Computer System Validation (CSV) experience in pharmaceutical or life sciences environments.
• Experience with test script authoring and execution for GxP systems.
• Experience supporting Master Data Governance processes (SAP experience preferred but not required).

Mansioni

• 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

Conoscenze

CSV validation

Test script authoring

GxP compliance

Data integrity

Independent work

Formazione

Bachelor's degree in Computer Science, Engineering, Life Sciences, or related discipline

Strumenti

Val Genesis

SAP

Snowflake

Descrizione del lavoro

Katalyst CRO is seeking a CSV Validation Engineer in New Jersey to author and execute validation scripts for GxP systems, focusing on ERP Master Data Governance and Data Lake validation. The role requires strong experience in CSV testing and regulatory compliance, collaborating with IT, QA, and Data Engineering teams.

Responsibilities include IQ/OQ/PQ validation activities, data integrity assurance, and maintenance of validation documentation, with emphasis on adherence to 21 CFR Part 11 and