Computer System Validation

Responsibilities

• Developing Engineering documentation such as URS, Design Specifications (FS, HDS, and SDS, etc.).
• Developing Deliverables & Documentation for BMS, EMS, ELVS & Automation System.
• Testing, Commissioning (FAT, SAT) and Qualification of the BMS, EMS, ELVS & Process Control system (Generation & Execution of Qualification Protocols).
• Well versed with Control System Validations for Process Control System (PCS), Building Management System (BMS), Environmental Monitoring System (EMS) & Extra Low Voltage System (ELVS).
• Development of SOP’s, Change Control Management, Deviation Handling and CAPAs., Root Cause Analysis & Failure Investigation., Leveraging Assessment etc.
• Development of Traceability Matrices, GAP Analysis and Final Reports.
• Performing Risk assessments, developing Risk Mitigation Plan and documenting Risk Assessment Reports (RAR), Performing Component Level Impact Assessment (CLIA) for BMS, EMS & PCS system.
• Ability to effectively lead projects, coordinate contractors, junior level personnel and drive results.
• Working closely with Systems Integrators, Automation leads, HVAC Leads & Process leads.
• Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments.