CSV Engineer

Katalyst CRO; New Jersey; On-site; USD 120,000 - 150,000; Full time

Job summary

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

Qualifications

• 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).

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

Skills

CSV validation

Test script authoring

GxP compliance

Data integrity

Independent work

Education

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

Tools

Val Genesis

SAP

Snowflake

Job description

Summary

CSV Validation Engineer is responsible for authoring and executing validation test scripts to support regulated systems within a GxP life sciences environment.

Summary

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