CSV Role - CSL

Job Overview:

We are seeking a Lead CSV/CSA Engineer to support GxP compliance activities across Data Analytics, Artificial Intelligence (AI), Machine Learning (ML), and Digital platforms. This role will work closely with Quality, IT, Data Analytics, and business stakeholders to ensure systems are implemented, maintained, and operated in compliance with applicable regulations, internal procedures, and data integrity requirements.

Lead Validation Engineer Responsibilities:

• Provide CSA / CSV subject matter expertise across Data Analytics, AI, Machine Learning, and Digital platforms
• Support system implementations, enhancements, integrations, upgrades, and data migrations from a compliance perspective
• Develop and review validation deliverables including Validation Plans, Risk Assessments, Traceability Matrices, and Validation Summary Reports
• Review and approve lifecycle documentation (URS, specifications, test plans, test summaries) in alignment with ALCOA+ and Good Documentation Practices
• Assess AI/ML solutions and analytics platforms to determine appropriate risk-based assurance activities
• Oversee validation readiness and ensure prerequisites are met prior to formal testing
• Support change control, configuration management, and release activities
• Partner with Quality, System Owners, Data Owners, and Business Process Owners to ensure ongoing compliance
• Provide guidance on CSA-based, risk-driven validation approaches for analytics and AI-enabled solutions
• Support supplier assessments, vendor documentation reviews, and leveraging of vendor testing where appropriate

Requirements:

• 5 8 years of hands-on experience supporting GxP systems, Data Analytics platforms, Artificial Intelligence solutions, or a combination of these domains
• Hands-on experience supporting cloud-based, SaaS, COTS, or enterprise data platforms in regulated environments
• Strong understanding of CSA principles, CSV, and SDLC processes
• Experience authoring and/or reviewing validation documentation
• Working knowledge of GxP regulations (e.g., FDA, EMA, ICH), data integrity requirements, and ALCOA+ principles
• Familiarity with AI, Machine Learning, advanced analytics, or business intelligence platforms
• Ability to work independently in a fast-paced, matrixed environment
• Strong communication skills and comfort interacting with Quality, IT, Data, and business stakeholders
• Experience Machine Learning, Business Intelligence, Data Lake, Data Warehouse, or Digital Transformation platforms preferred
• Experience with technologies such as Power BI, Tableau, Snowflake, Databricks, Azure, AWS, Google Cloud, or similar platforms preferred
• Familiarity with electronic quality systems, change management tools, or application lifecycle management platforms preferred
• Experience supporting AI governance, model lifecycle management, or emerging AI compliance frameworks preferred

Himanshu Goswami

Sr. IT Technical Recruiter

Stellent IT Phone:

Email: Himanshu.goswami
Gtalk: Himanshu.goswamiom