Commissioning & Qualification Engineer

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