Senior CSV Engineer: Lead Validation for GxP Systems

ALLIANCE BIOTECH SOLUTIONS LLC; Raleigh (NC); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical, Dental & Vision Insurance

401k with employer contributions

Flexible PTO

Bonus plans

Job summary

Alliance Biotech Solutions in Raleigh, NC seeks a Senior CSV Engineer to lead validation of complex systems, databases, and BI platforms within regulated environments. You will partner across IT, data engineering, manufacturing, and QA to ensure compliance during the full SDLC.

The role emphasizes validation strategy, SQL testing, data integrity, and documentation for audits, with opportunities to shape validation best practices in a biotech context.

Qualifications

• Lead CSV activities for custom-developed applications, enterprise databases, data platforms, and GxP systems.
• Define validation strategies with IT, QA, and business stakeholders to ensure compliance.
• Author and execute IQ/OQ/PQ protocols, validation plans, risk assessments, and traceability matrices.
• Validate dashboards, data pipelines, and cloud data platforms using SQL-based testing and data reconciliation.
• Verify data integrity, security, audit trails, and electronic records controls per regulatory standards.
• Maintain validation documentation and support audit readiness across CSV, CSA, and data integrity practices.

Responsibilities

• Lead validation across the software development lifecycle for core systems and integrations.
• Collaborate with software developers, data engineers, IT, and Quality to align validation activities with business goals.
• Review and sign off on validation deliverables including test scripts and validation summaries.
• Provide technical leadership on CSV/CSA, data integrity, and regulatory compliance to project teams.

Skills

CSV validation

SQL & Databases

Power BI

Regulatory compliance

GxP

Cross-functional collaboration

Education

Bachelor's degree in Engineering / Computer Science / Life Sciences

Tools

Azure Data Lake

Databricks

Synapse

SQL Server

Oracle

PostgreSQL

Job description

Alliance Biotech Solutions in Raleigh, NC seeks a Senior CSV Engineer to lead validation of complex systems, databases, and BI platforms within regulated environments. You will partner across IT, data engineering, manufacturing, and QA to ensure compliance during the full SDLC.

The role emphasizes validation strategy, SQL testing, data integrity, and documentation for audits, with opportunities to shape validation best practices in a biotech context.