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
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
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
Benefits
Working in a regulatory environment in the growing field of life sciences
Opportunity to work with advanced technologies and systems such as Data Lakes and AI
Collaborative work with cross-functional teams, enhancing professional networking and experience
Possibility for professional development with exposure to GxP and regulatory compliance standards
Full 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. 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
