Validation Engineer


Category: Manufacturing

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Validation Engineer

Do you want to be part of the team in the No 1 Great Place to Work company in Ireland? If your answer is Yes then we might have the right role for you at AbbVie, Manorhamilton Road, Sligo. We are currently sourcing a Validation Engineer to co-ordinate, implement and actively participate in the site Validation Program.

Key Responsibilities:

  • Ensuring all Computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements.
  • Co-ordination / direction and active participation in the validation of site equipment, facilities, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
  • Maintenance/Generation of the Validation Master Plans.
  • Generation/maintenance of Project Validation Plans.
  • Generation of validation plans, protocols and final reports to cGMP standard.
  • Review / approval of all protocols and final reports.
  • Management of validation change control process.

Education:

  • 3rd level qualification in a relevant engineering or scientific discipline

Technical:

  • A minimum of 2 years experience in a cGMP regulated environment.

Abbvie

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