Job Description
Overview
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...