Validation Engineer - Validation Tester with RPA AND AI

As a Validation Engineer specializing in RPA and AI, your role will involve supporting validation activities for computerized systems, automated testing solutions, RPA workflows, and AI-enabled validation tools in a regulated pharmaceutical and life sciences environment. You will play a crucial part in ensuring validation efficiency, testing accuracy, and compliance readiness through the application of RPA and AI technologies. Key Responsibilities: - Design, develop, review, and execute validation test scripts and test cases for GxP-regulated computerized systems. - Support validation of RPA and AI-enabled solutions used in validation testing, quality systems, and compliance processes. - Translate requirements into formal test cases in collaboration with business users, QA, IT, and validation teams. - Perform verification and validation activities including functional testing, regression testing, data validation, and system qualification. - Maintain validation documentation such as Validation Plans, Test Plans, Test Scripts, RTM, Risk Assessments, IQ/OQ/PQ documents, and Validation Summary Reports. - Implement RPA tools to automate repetitive validation testing activities and documentation workflows. - Evaluate and validate AI-based tools or models used in testing, data review, defect detection, documentation review, or compliance monitoring. - Ensure all validation activities comply with GxP, GMP, CSV, 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity requirements. - Collaborate with cross-functional teams in an Agile environment for sprint planning, user story review, defect triage, and status reporting. - Support audit readiness by ensuring accurate, complete, and inspection-ready validation documentation. Required Qualifications: - 5+ years of experience in pharmaceutical, life sciences, or regulated validation environments. - Strong experience in Computer System Validation, GxP validation, and GMP-regulated systems. - Experience authoring and executing formal test scripts and test cases based on business requirements and system specifications. - Knowledge of validation documentation including URS, FRS, RTM, IQ, OQ, PQ, Validation Plan, Test Plan, and Validation Summary Report. - Experience with RPA tools or automation testing concepts. - Understanding of AI usage in validation testing, documentation review, or quality/compliance processes. - Strong knowledge of regulatory standards such as GAMP 5, 21 CFR Part 11, EU Annex 11, GMP, GxP, and data integrity principles. - Familiarity with Agile delivery methodology. - Strong documentation, communication, and stakeholder coordination skills. As a Validation Engineer specializing in RPA and AI, your role will involve supporting validation activities for computerized systems, automated testing solutions, RPA workflows, and AI-enabled validation tools in a regulated pharmaceutical and life sciences environment. You will play a crucial part in ensuring validation efficiency, testing accuracy, and compliance readiness through the application of RPA and AI technologies. Key Responsibilities: - Design, develop, review, and execute validation test scripts and test cases for GxP-regulated computerized systems. - Support validation of RPA and AI-enabled solutions used in validation testing, quality systems, and compliance processes. - Translate requirements into formal test cases in collaboration with business users, QA, IT, and validation teams. - Perform verification and validation activities including functional testing, regression testing, data validation, and system qualification. - Maintain validation documentation such as Validation Plans, Test Plans, Test Scripts, RTM, Risk Assessments, IQ/OQ/PQ documents, and Validation Summary Reports. - Implement RPA tools to automate repetitive validation testing activities and documentation workflows. - Evaluate and validate AI-based tools or models used in testing, data review, defect detection, documentation review, or compliance monitoring. - Ensure all validation activities comply with GxP, GMP, CSV, 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity requirements. - Collaborate with cross-functional teams in an Agile environment for sprint planning, user story review, defect triage, and status reporting. - Support audit readiness by ensuring accurate, complete, and inspection-ready validation documentation. Required Qualifications: - 5+ years of experience in pharmaceutical, life sciences, or regulated validation environments. - Strong experience in Computer System Validation, GxP validation, and GMP-regulated systems. - Experience authoring and executing formal test scripts and test cases based on business requirements and system specifications. - Knowledge of validation documentation including URS, FRS, RTM, IQ, OQ, PQ, Validation Plan, Test Plan, and Validation Summary Report. - Experience with RPA tools or automation testing concepts. - Understanding of AI usage in validation testin