Validation Engineer Role

2 weeks ago


Waterford, Waterford, Ireland beBeeValidation Full time €60,000 - €80,000
Job Title: Validation Engineering Specialist

The role of the Validation Engineering Specialist is to ensure the ongoing validation and compliance of equipment, systems, and processes.

This includes:

  • Designing, executing, and reporting on PV/Process Performance Qualifications.
  • Validating equipment, systems, and processes in accordance with standards and legal requirements.
  • Providing guidance on regulatory requirements for aseptic processing, lyophilisation, sterilisation, and depyrogenation.
  • Maintaining validation documentation throughout the lifecycle.
  • Participating in external regulatory inspections.
  • Supporting Site Change Control processes.
Key Responsibilities:
  • Troubleshoot validation issues related to projects and process development.
  • Apply technical knowledge of pharmaceutical plants.
  • Utilize experience in validation/product development.
  • Knowledge of Process Validation regulations and industry practices.
  • Understand GAMP, ISPE guides, and validation publications such as AAMI/ANSI, PDA, ISO.
  • Appreciate quality and compliance regulations.
  • Ability to execute projects as planned.
  • Good understanding of quality management systems.
  • Strong communication skills.
  • Experience with MS Project and SPC packages is advantageous.
  • Understanding of site KPIs.

As a key member of our team, you will be responsible for ensuring that all aspects of validation are carried out in accordance with regulatory requirements. You will also provide support to other departments as needed.


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