Process Validation Engineer

Job description

Process Validation Engineer



I have a new Process Validation Engineer role in Cork with a leading Pharma company. If you have the following experience and are interested apply today by sending your CV to


What you will do in this process validation engineer role:

  • End to end support of Manufacturing process validation.
  • validate the manufacturing process
  • Perform statistical analysis to prove the manufacturing process capability
  • Support in overall delivery of the project.
  • Responsible for verifying and validation of several machines and various process involved in it.
  • Responsible for IQ/OQ/PQ methodologies and report generation.
  • Preparing document in business process by identifying the business requirements.
  • Understanding functional specifications and system design specifications for client
  • Analyse issues recurrence to identify patterns and gaps identification, drive root cause
  • analysis, and translate findings into solutions to improve workflows, processes and tools
  • Interaction with manufacturing and design team to identify improvement areas in
  • manufacturing process
  • Interaction with supply chain management team related to manufacturing activities
  • Implementation and follow the operational standards, policies and procedures.
  • Optimization of manufacturing processes and methodologies
  • Mitigate risks reported during the project
  • Documentation of process change in engineering change management system

Job Requirements

  • Exposure to ISO13485 and ISO14971 medical standards and have exposure to risk assessment
  • techniques to evaluate the associated risks, to control these risks, and to monitor the
  • effectiveness of the controls.
  • Knowledge of any 3D CAD software.
  • Strong Technical Knowledge in Manufacturing Engineering
  • Knowledge in test method development validation, development and transfer.
  • Knowledge in stages of qualification like design, installation, operational and performance.
  • Knowledge in preparing manufacturing process control flow chart.
  • Knowledge in Risk management and Change management process.
  • Knowledge in creation of Pareto chart, why-why analysis, cause & effect diagram for analysis


Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.