Review of process flow diagrams (PFDs), piping & instrumentation diagrams (P&IDs), valve matrices, sequences for Process vessels interconnection & transfer lines.
Support the design, specification and qualification of process and utilities equipments for BioPharma / Pharma or Plasma Fractionation facilities.
Review process design & engineering to meet technical, cGMP & regulatory expectations.
Create project specifications including Equipment Data-sheets and URS s.
Support in calculation of plant capacity sizing, mass flow balance, utility systems and occupancy matrix for individual process equipment.
Perform hydraulic calculations and pump sizing. Perform heat exchanger sizing.
Liaise with OEM /Suppliers to ensure correct specification of equipment & utilities.
Specify requirements for utilities and support services; create Room Data-sheets to support manufacturing operations.
Review Functional Specification for automated process operations; create automation matrices, description of process alarms and interlocks.
Support construction activities at client sites; perform site walk-downs in support of mechanical completion.
Create commissioning & qualification (C&Q) protocols, execution reports. Support closure of discrepancies created during protocol execution.
Perform or support execution of C&Q protocols for process/CIP and utility systems, clean rooms and facilities.
Perform safety risk assessments and HAZOP studies and Perform other activities related to plant start-up.
Perform gap analysis against specific objective and quality risk assessment for existing design or existing facility.
Review and execute C&Q protocols for process and utility systems.
Perform all qualification activities (FAT, SAT, IQ, OQ and PQ ) for automated systems (integrated with process vessels and other biprocess equipments).
Perform and support safety analysis, prepare sizing criteria and perform sizing of pressure relieving devices.
