5-7 years
2 months ago 3 Applied
Job Description

  • Review of process flow diagrams (PFDs), piping instrumentation diagrams (PIDs), 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 (CQ) protocols, execution reports. Support closure of discrepancies created during protocol execution.
  • Perform or support execution of CQ 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 CQ 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.






heat exchanger sizing
process design engineering
HAZOP studies
pressure relieving devices
cGMP regulatory expectations

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