Lead Validation Engineer

Verista, Inc.•King of Prussia, PA

1d•$87,780 - $118,062•Remote

About The Position

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise 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.

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

Nice To Haves

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

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