🔹 Job Title: AI Validation & Documentation Engineer 💼 Employment Type: Full-Time | Contract-to-Hire / Direct Hire 📅 Experience Required: 3+ years in validation, documentation, or QA with exposure to AI/ML systems 🌐 Industry: Pharmaceutical / Life Sciences About the Role We are looking for an AI Validation & Documentation Engineer to lead the validation and regulatory documentation of AI and machine learning systems across pharmaceutical operations—spanning clinical, manufacturing, and regulatory environments. This role ensures AI/ML models meet GxP, FDA 21 CFR Part 11, and global compliance standards while maintaining robust documentation, risk assessment, and lifecycle management. You’ll work closely with data scientists, software engineers, QA, and regulatory teams to ensure AI systems are reliable, explainable, and audit-ready. Key Responsibilities • Develop and execute AI/ML validation protocols to ensure accuracy, reproducibility, and compliance. • Create and maintain validation documentation: plans, traceability matrices, test scripts, reports, and audit trails. • Collaborate with data science teams to evaluate model design, training data, metrics, and drift risks. • Conduct risk assessments covering bias, explainability, and version control. • Ensure compliance with GxP, GAMP 5, 21 CFR Part 11, Annex 11, and ALCOA+ principles. • Support Computer System Validation (CSV) of AI-based platforms in R&D and manufacturing. • Serve as SME during audits and regulatory inspections for AI system validation. • Maintain SOPs for AI validation and governance. • Track and document changes in AI models, pipelines, and workflows. Required Qualifications • Bachelor’s or Master’s in Engineering, Life Sciences, Computer Science, or related field. • 3+ years in validation, QA, or regulatory documentation in pharma/biotech. • Experience with AI/ML lifecycle management and model validation principles. • Strong knowledge of GAMP 5, GxP, 21 CFR Part 11, ICH Q8/Q9/Q10. • Proficiency in writing validation protocols, reports, and traceability documentation. • Familiarity with AI interpretability, bias mitigation, and version control. Preferred Qualifications • Hands-on experience with AI/ML tools (TensorFlow, PyTorch, MLflow). • Experience in AI audits or regulatory submissions (FDA, EMA). • Familiarity with EDMS platforms (Veeva Vault, MasterControl). • Certifications in GAMP 5, Six Sigma, AI Risk & Compliance are a plus.