Computer system validation specialist/engineer

CSV (Computer System Validation), GxP, GAMP5, Data integrity, Data Validation, Audit trails, Risk Assessments, Risk Mitigation, Software Testing, Software Development Life Cycle (SDLC), CQV (Commissioning,Qualification & Validation), Equipments Validation, Troubleshooting, Validation Tests, Validation Protocols, Lifecycle Management, Quality Management System, Risk Management, Risk Analysis, Deviation Management, Change Control, Product Lifecycle, Automation, Test Scripts, Test Cases, Test Execution, SaaS, Cloud Computing, Enterprise Resource Planning (ERP), Data processing, Maintenance, Process Improvement, Stakeholders, Statistical Process Control (SPC), Failure Mode Effect Analysis (FMEA), Corrective and Preventive Action (CAPA), Analytical Reasoning, Problem Solving, Project Management. Kneat Gx, MasterControl, TrackWise, Agile, Jira, Enterprise Resource Planning (ERP), SAP ERP, Laboratory Information Management System (LIMS), Quality Management System (QMS), Manufacturing Execution System (MES), Document Management System (DMS), Microsoft Excel.