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Job offer description

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
Job details
Work experience:
Work experience is not required
Language skills:
  • English
  • Good
Salary range:
Not provided
Date of expiry:

About company

DPS Engineering are an international provider of professional services in Process Engineering Design and Project Management.Our sector expertise spans many markets including Biotechnology, Pharmaceutical, Medical Technologies, Oil and Gas, Advanced Technology, Food & Beverage, Energy and Science & Education.https://www.dpsgroupglobal.com/ Find out more