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.
