Senior Qualification Specialist

1 week ago

Waterford, Waterford, Ireland Eir evo talent Full time
About the Role

This is an exciting opportunity to join our team as a Validation Engineer. In this role, you will be responsible for supporting new product introductions, equipment qualification, and site requalification programs.

Your Key Responsibilities will include:

  • Designing, executing, and reporting on PV/Process Performance Qualifications.
  • Designing, executing, and reporting on validation studies for equipment, systems, and processes.
  • Ensuring validation studies are managed in accordance with all required standards and legal requirements (Health & Safety, cGMP, construction, environmental, etc.).
  • Providing technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation, and depyrogenation.
  • Maintaining validation documentation throughout the validation lifecycle.
  • Participating in external regulatory inspections.
  • Supporting Site Change Control process.
What We Are Looking For

We are seeking a skilled and experienced Validation Engineer to join our team. To be successful in this role, you should have:

  • Troubleshooting skills for validation issues associated with projects and process development.
  • Technical knowledge of pharmaceutical plants.
  • Previous validation/product development experience is highly advantageous.
  • Knowledge of Process Validation regulations, current process validation and technical transfer industry practices, and experience of interpreting and applying guidelines and regulations.
  • Knowledge of GAMP, ISPE Baseline guides, and steam and dry heat validation publications such as AAMI/ANSI, PDA, and ISO guidelines.
  • A full understanding of relevant quality and compliance regulations.
  • The ability to execute projects to plan.
  • Good knowledge of quality management systems.
  • Excellent communication skills at organization, team, and individual levels.
  • The ability to use MS Project and SPC packages is an advantage.
  • An understanding of KPIs for the site.

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