Lead Validation Engineer, Data Analytics/AI

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Deliver subject matter expertise in CSA / CSV within the realms of Data Analytics, AI, Machine Learning, and Digital platforms.

• Assist in system implementations, enhancements, integrations, upgrades, and data migrations from a compliance viewpoint.

• Create and evaluate validation deliverables such as Validation Plans, Risk Assessments, Traceability Matrices, and Validation Summary Reports.

• Review and authorize lifecycle documentation (URS, specifications, test plans, test summaries) in accordance with ALCOA+ and Good Documentation Practices.

• Evaluate AI/ML solutions and analytics platforms to identify suitable risk-based assurance activities.

• Supervise validation readiness and confirm that prerequisites are fulfilled before formal testing.

• Aid in change control, configuration management, and release activities.

• Collaborate with Quality, System Owners, Data Owners, and Business Process Owners to maintain ongoing compliance.

• Offer guidance on CSA-based, risk-driven validation strategies for analytics and AI-enabled solutions.

• Assist in supplier assessments, vendor documentation reviews, and utilize vendor testing when applicable.

⛳️ Requirements

• 5–8 years of practical experience supporting GxP systems, Data Analytics platforms, Artificial Intelligence solutions, or a combination of these fields.

• Practical experience with cloud-based, SaaS, COTS, or enterprise data platforms in regulated settings.

• Solid understanding of CSA principles, CSV, and SDLC processes.

• Experience in authoring and/or reviewing validation documentation.

• Familiarity with GxP regulations (e.g., FDA, EMA, ICH), data integrity standards, and ALCOA+ principles.

• Knowledge of AI, Machine Learning, advanced analytics, or business intelligence platforms.

• Capability to work independently in a dynamic, matrixed environment.

• Excellent communication skills and comfort in engaging with Quality, IT, Data, and business stakeholders.

• Preferred experience with Machine Learning, Business Intelligence, Data Lake, Data Warehouse, or Digital Transformation platforms.

• Preferred familiarity with technologies such as Power BI, Tableau, Snowflake, Databricks, Azure, AWS, Google Cloud, or similar platforms.

• Preferred understanding of electronic quality systems, change management tools, or application lifecycle management platforms.

• Preferred experience in supporting AI governance, model lifecycle management, or emerging AI compliance frameworks.

🏝️ Benefits

• High growth potential in a fast-paced organization with a people-centered culture.

• Competitive salary along with performance-based incentive programs.

• Company-funded Life, Short-Term, and Long-Term Disability Insurance.

• Medical, Dental & Vision insurance options.

• FSA, DCARE, and Commuter Benefits.

• Supplemental Life, Hospital, Critical Illness, and Legal Insurance.

• Health Savings Account.

• 401(k) Retirement Plan with employer matching benefits.

• Paid Time Off (with rollover option) and recognized holidays.

• As-needed sick leave.

• Tuition reimbursement opportunities.

• Team social activities (we believe in having fun!).

• Employee recognition programs.

• Employee referral incentives.

• Paid parental leave and bereavement support.