Commissioning & Qualification Engineer

by:  DPS Engineering

La oferta de empleo está disponible para el siguiente evento:

Duties:

  • Prepare and execute qualification documents for process equipment, systems and processes.
  • Writing technical reports on qualification activities, investigative report writing, risk assessment, and review/approval of engineering and validation documents i.e. IQ/OQ/PQ.
  • Review of vendor prepared/executed commissioning & validation documentation
  • Provide validation engineering support to quality control, engineering, maintenance, manufacturing and warehouse departments
  • Reporting of Validation non-conformances and providing solutions to remediate issues
  • Raise and implement critical system change requests
  • Create new standard operating procedures, review and update existing operational documentation.
  • Working with cross function departments to ensure solutions are implemented in an efficient and effective manner
  • Processing documentation through the document management system
  • Periodic review of documentation management system workflows to ensure both regulatory & business needs are satisfied

Education/Experience Requirements:

  • B.Sc. or M.Sc./MEng Degree in Science, Chemical or Biopharmaceutical or equivalent discipline
  • Minimum of 2 years’ experience in a cGMP manufacturing environment
  • Experience in both equipment and process validation experience is desirable
  • Knowledge of FDA and EU regulations pertinent to aseptic processing, in particular, is desirable
  • Report, standards, policy writing skills required

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