Engineer of Process Assurance

2 weeks ago


Waterford, Waterford, Ireland beBeeValidation Full time €50,000 - €80,000
Validation Engineer Role

The role of a Validation Engineer involves ensuring the quality and reliability of pharmaceutical equipment, systems, and processes.

  • Design and execute validation studies to test the performance of equipment, systems, and processes.
  • Develop and maintain technical documentation to support validation activities.
  • Analyze data from validation studies to identify areas for improvement.
  • Collaborate with cross-functional teams to implement process improvements.
  • Maintain regulatory compliance by adhering to FDA and EU guidelines.

Requirements:

  • Bachelor's degree in Science (Chemistry, Microbiology, or Pharmacy) or Engineering (Chemical/Mech/Elec).
  • Previous experience in validation or product development is an asset.
  • Familiarity with GAMP, ISPE Baseline guides, and relevant regulations.
  • Strong understanding of quality management systems and communication skills.
  • Proficiency in MS Project and SPC packages is an advantage.


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