CSV Engineer

ALLIANCE BIOTECH SOLUTIONS LLC•Raleigh, NC

About The Position

The Senior Computer System Validation (CSV) Engineer is responsible for leading the validation of complex computerized systems, custom-developed applications, enterprise databases, data platforms, and business intelligence solutions used within regulated GxP environments. This role partners with IT, Software Development, Data Engineering, Manufacturing, Quality, and business stakeholders to ensure that custom software applications, databases, reporting platforms, and system integrations are designed, validated, and maintained in compliance with regulatory requirements and industry best practices. This position requires an experienced validation professional who is equally comfortable discussing validation strategy with Quality, reviewing software architecture with developers, validating SQL queries and database structures, and ensuring the integrity of data flowing between enterprise systems. The successful candidate will lead validation efforts across the full software development lifecycle, with particular emphasis on custom applications, relational databases, enterprise data warehouses/lakehouses, data pipelines, APIs, and business intelligence platforms that support manufacturing, laboratory, and business operations.

Requirements

Bachelor's degree in Engineering, Computer Science, Information Systems, Software Engineering, Life Sciences, or a related technical discipline.
7+ years of Computer System Validation (CSV) experience supporting custom software applications, enterprise databases, data platforms, and computerized systems within pharmaceutical, biotechnology, medical device, or other regulated industries.
Demonstrated experience validating custom-developed applications, database-driven systems, enterprise integrations, and business intelligence platforms such as Power BI.
Strong knowledge of relational databases, SQL, data architecture, data validation methodologies, and cloud-based data platforms such as Azure Data Lake, Databricks, Synapse, OneLake, SQL Server, Oracle, PostgreSQL, or similar technologies.
Thorough understanding of GAMP 5, Computer Software Assurance (CSA), 21 CFR Part 11, EU Annex 11, ALCOA+ Data Integrity principles, and cGMP regulations.
Experience leading validation efforts across the software development lifecycle, including requirements, risk assessments, testing, documentation, and audit readiness.
Excellent analytical, troubleshooting, communication, and cross-functional collaboration skills.

Responsibilities

Lead Computer System Validation (CSV) activities for custom-developed applications, enterprise databases, data platforms, dashboards, and other GxP computerized systems.
Partner with software developers, data engineers, IT, Quality, and business stakeholders to define validation strategies and ensure compliance throughout the software development lifecycle.
Author and execute validation deliverables including Validation Plans, URS, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, test scripts, and Validation Summary Reports.
Validate custom applications, Power BI dashboards, enterprise databases, and cloud-based data platforms while performing SQL-based testing, data reconciliation, and verification activities.
Validate system integrations, data pipelines, APIs, and interfaces between enterprise applications including LIMS, MES, ERP, PI Historian, and related GxP systems.
Verify data integrity, security, audit trail, and electronic records controls to ensure compliance with GxP and regulatory requirements.
Support audit readiness by maintaining compliant validation documentation and providing technical leadership on CSV, CSA, database validation, and data integrity best practices.