Product Validation Expert

10 hours ago

Cork, Cork, Ireland beBeeEngineering Full time €60,000 - €80,000

Validation Specialist

We are seeking a skilled validation specialist to oversee equipment, systems and processes in our company. The successful candidate will have experience in aseptic processing, lyophilisation, sterilisation and depyrogenation.

Main Responsibilities:

  • Design and execute PV/Process Performance Qualifications.
  • Validate equipment, systems and processes through thorough studies and reports.
  • Provide technical interpretation and guidance on current US FDA and EU validation requirements.
  • Maintain accurate validation documentation throughout the validation lifecycle.
  • Collaborate with cross-functional teams during external regulatory inspections and site change control processes.
  • Troubleshoot validation issues associated with projects and process development.

Key Skills and Qualifications:

  • Degree in Science (Chemistry, Microbiology or Pharmacy preferred) or Engineering (Chemical/Mech/Elec).
  • Previous validation/product development experience is highly advantageous.
  • Strong knowledge of Process Validation regulations, industry practices and guidelines.
  • Familiarity with GAMP, ISPE Baseline guides and relevant quality regulations.
  • Proficiency in MS Project and SPC packages is an advantage.

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