Computer Systems Validation Expert

1 day ago

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

System Validation Specialist

A skilled System Validation Specialist is required to ensure the validation of computerised equipment and systems in a pharmaceutical manufacturing environment. The successful candidate will have experience with CSV validation and be able to work on site with occasional remote working.

Key Responsibilities:

  • Validate new computerised equipment and control systems, generating documentation and providing assistance with execution.
  • Participate in change control processes, advising on CSV issues as necessary.
  • Develop and execute DQ, IQ, OQ and PQ activities, ensuring compliance with regulatory requirements.
  • Design and implement validation studies for manufacturing and control equipment, including critical systems and facilities.
  • Provide technical assistance on current US FDA and EU validation requirements.
  • Maintain validation documentation and ensure compliance with cGMP at all times.
  • Approve and implement changes to relevant systems and assist in generating validation/revalidation plans.

Requirements:

  • Degree in Science (Chemistry, Microbiology or Pharmacy preferred) or Engineering (Chemical/Mech/Electrical).
  • 3-5 years' experience in a Healthcare manufacturing environment, ideally in the pharmaceutical sector.
  • 2-3 years' experience in a validation environment.

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