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Data Validation Specialist

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Waterford, Waterford, Ireland beBeeCSVEngineer Full time €60,000 - €80,000

Catalyx is currently seeking a skilled CSV Engineer to play a crucial role in ensuring the ongoing validation compliance of computerised equipment and systems within a sterile manufacturing environment.

The Job Role

As a key member of our team, you will be responsible for leading and supporting validation activities for new and existing computerised equipment and control systems. Your tasks will include generating validation documentation (protocols/reports) and assisting with the execution of validation protocols.

Key Responsibilities:
  • You will participate in the change control process, providing expert advice on CSV matters.
  • You will contribute to the development and execution of DQ, IQ, OQ, and PQ protocols.
  • You will ensure all projects are delivered in line with cGMP, Health Safety, environmental, and regulatory standards.
  • You will design, implement, and execute validation studies for manufacturing and control systems, including critical utilities and facilities.
  • You will provide guidance on current US FDA and EU validation requirements for sterile processing, including aseptic techniques, lyophilisation, and sterilisation.
Required Skills and Qualifications:
  • You should hold a degree in Science (Chemistry, Microbiology, or Pharmacy preferred) or Engineering (Chemical/Mechanical/Electrical).
  • A post-graduate qualification is desirable.
  • You should have 3–5 years' experience in a healthcare manufacturing environment, ideally within the pharmaceutical sector.
  • You should have 2–3 years' experience in a validation or CSV role.
  • You should possess project management skills.
Why Choose This Opportunity?

We offer a Total Rewards package that includes great professional growth opportunities. Our company is an Equal Opportunity Employer, committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported.