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Computer Systems Validator

2 weeks ago


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

This job opportunity focuses on the validation of computerised systems, ensuring they meet required standards and regulations.

Key Responsibilities
  • Develop and execute protocols for validating new equipment and control systems.
  • Create comprehensive documentation to support validation processes.
  • Collaborate with teams to implement change control procedures and provide expert advice on CSV issues.
  • Conduct hands-on activities related to DQ, IQ, OQ, and PQ tasks.
  • Ensure compliance with Sanofi's and regulatory requirements (Health & Safety, cGMP, construction, environmental etc).

The ideal candidate will possess experience in a healthcare manufacturing environment, preferably within the pharmaceutical sector. They should also be familiar with US FDA and EU validation requirements for lyophilization, aseptic processing, and sterilisation.

Requirements
  • Bachelor's degree in Science (Chemistry, Microbiology, or Pharmacy) or Engineering (Chemical/Mech/Elec).
  • Minimum 3-5 years of experience in a healthcare manufacturing setting, ideally in the pharmaceutical sector.
  • At least 2-3 years of experience in a validation environment.