Position: Commissioning & Qualification Engineer Responsibilities
Develop risk assessment, system impact assessments, validation plans, protocols and reports that support the qualification and validation of systems. Develop and execute Commissioning and validation Protocols for Bioprocess Equipment's. Develop and execute Commissioning and validation of Clean Rooms, HVAC systems, EMS and BMS Systems, Clean utilities and black utilities system. Develop Protocols and Conduct Tests like HEPA Filter Integrity Testing, Air velocity, Recovery Testing, ACPH, Airflow pattern study, DP monitoring, non-viable particle counting, Viable Particle Counting, etc. Develop and execute Commissioning and validation of Pharma Process Equipment's for API, Fill/Finish and OSD. Preparation of System Boundaries, SLIA, CLIA, QRA, Facility Risk Assessments. Review, analyze and interpret system performance data for completed validation and prepare final report packages by summarizing the data. Investigate devi...