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    Validation Engineer Contractor - Sligo, Ireland - TEAM HORIZON

    TEAM HORIZON
    TEAM HORIZON Sligo, Ireland

    1 week ago

    team horizon background
    Freelance
    Description
    Team Horizon is seeking a Validation Engineer for a 12-month contract for our client's manufacturing facility in Sligo.

    Why you should apply:

  • Exciting opportunity to join a global pharmaceutical company and join a dierse and experienced team

    • What you will be doing:

  • Ensure 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.
  • Generation/maintenance 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.
  • Adheres to and supports all EHS & E standards, procedures and policies

    • What you need to apply:

  • 3rd level qualification in a relevant engineering or scientific discipline.
  • A minimum of 5-10 years' experience in a cGMP regulated environment.
  • A good understanding of regulatory requirements.
  • Experience in Process validation (PPQ) in API or Drug product and experience with managing validation events / Non-Conformances during PPQ
  • FUE qualification essential (preferably API). Experience with working in fast paced projects. Understanding of ASTM E risk-based qualification.
  • Good understanding of Critical Process Parameters/ Non critical process parameters and their relationship with instrument calibration tolerances and selection of PPQ test criteria
  • Ability to work directly with Engineering and other stakeholders to understand validation requirements.
  • Ability to react to problems quickly during validation.
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