CSV Validation Specialist

14 hours ago

Waterford, Waterford, Ireland beBeePharmaceutical Full time €60,000 - €90,000
CSV Validation Specialist

Catalyx is seeking a CSV validation specialist to work in a manufacturing environment.

The Role
  • Lead and support validation activities for new and existing computerised equipment and control systems.
  • Generate validation documentation (protocols/reports) and assist with the execution of validation protocols.
  • Participate in the change control process, advising on CSV matters.
  • Contribute to the development and execution of DQ, IQ, OQ, and PQ protocols.
  • Ensure all projects are delivered in line with cGMP, Health & Safety, environmental, and regulatory standards.

Requirements

  • A degree in Science (Chemistry, Microbiology, or Pharmacy preferred) or Engineering (Chemical/Mechanical/Electrical).
  • Post-graduate qualification desirable.
  • 3–5 years' experience in a healthcare manufacturing environment, ideally within the pharmaceutical sector.
  • 2–3 years' experience in a validation or CSV role.
  • Project management experience.
  • Strong technical knowledge of pharmaceutical operations.
  • Familiarity with GAMP, ISPE Baseline Guides, and quality/compliance regulations.
  • Strong troubleshooting skills in validation projects.
  • Effective communication and facilitation skills, with ability to influence and work across multifunctional teams.

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