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Validation Specialist

2 weeks ago


Waterford, Waterford, Ireland beBeeValidation Full time €70,000 - €90,000

Job Overview

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A Validation Specialist is required to lead our pharmaceutical client's project. This 12-month contract offers a unique opportunity for a skilled professional in aseptic processing, lyophilisation, sterilisation, and depyrogenation.

Key Responsibilities

  • Developing and executing process performance qualifications and validation studies for equipment, systems, and processes.
  • Providing technical guidance on current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation, and depyrogenation.
  • Maintaining validation documentation throughout the validation lifecycle.
  • Supporting regulatory inspections and site change control processes.
  • Troubleshooting validation issues related to projects and process development.

Requirements

  • Degree in Science (Chemistry, Microbiology, or Pharmacy) or Engineering (Chemical/Mech/Elec).
  • Previous experience in validation/product development is advantageous.
  • Knowledge of Process Validation regulations, industry practices, and guidelines.
  • Understanding of quality and compliance regulations.
  • Ability to manage projects effectively.
  • Strong communication skills.

Benefits

This role offers a unique opportunity to develop your skills and expertise in validation and process development. If you are passionate about delivering high-quality results and working in a dynamic environment, this could be the ideal role for you.