Data Analytics/AI Validation Engineer/ Lead Validation Engineer (CSV/ CSA Engineer)

QvalFocus Inc. is seeking a Lead Validation Engineer to support Computer Software Assurance (CSA) and Computer System Validation (CSV) activities for Data Analytics, Artificial Intelligence (AI), Machine Learning (ML), and Digital platforms in a GxP-regulated environment. This role will partner with Quality, IT, Data Analytics, and Business stakeholders to ensure systems are implemented, maintained, and operated in compliance with regulatory requirements and data integrity standards.

Responsibilities:

• Lead CSA/CSV activities for AI, ML, Data Analytics, and Digital platforms
• Develop and review validation documentation, including Validation Plans, Risk Assessments, Traceability Matrices, and Validation Summary Reports
• Support system implementations, upgrades, integrations, data migrations, and change control activities
• Ensure compliance with GxP regulations, FDA requirements, ALCOA+ principles, and Good Documentation Practices
• Assess AI/ML and analytics solutions using risk-based validation approaches
• Collaborate with cross-functional teams to maintain compliance throughout the system lifecycle

Requirements:

• 5–8 years of CSA/CSV validation experience in regulated Life Sciences environments
• Strong knowledge of GxP, FDA regulations, SDLC, data integrity, and risk-based validation methodologies
• Experience with AI/ML, Data Analytics, Business Intelligence, or Digital Transformation platforms
• Hands-on experience with validation documentation and compliance activities
• Familiarity with cloud and enterprise technologies such as Azure, AWS, GCP, Databricks, Snowflake, Power BI, or Tableau
• Strong communication, leadership, and stakeholder management skills
• Experience with AI governance, model lifecycle management, supplier assessments, and electronic quality management systems (eQMS)