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Computer System Validation Engineer

Job description

Are you an experienced and enthusiastic CSV Engineer with experience providing IT systems validation and compliance expertise - looking for a new permanent opportunity with great suite of benefits?

Look no further - please read on!!!

           

Job Responsibilities

  • Managing CSV projects from software install to business release
  • Generating relevant documentation in accordance with site procedures and GMP guidelines
  • Liaising with service providers to determine successful installation of instrument software and ensuring correct configuration
  • Executing test scripts, analyzing test results and determining the acceptability of results against pre-determined criteria
  • Working with the business to identify and implement procedural controls to mitigate issues found during testing
  • Initiating and implementing Change Control activities in accordance with Quality Standards and Practices

 

Job Requirements

  • 3+ years’ experience validating IT applications (requirements gathering, design documentation, test case development, system & acceptance testing)
  • Degree qualified
  • Strong oral and written communication skills are required,
  • Experience of server and workstation platforms and working in a Win 10 environment
  • Familiar with Annex 11/21CFR Part 11 requirements, GAMP 5 and data integrity guidelines
  • Experience of working in a pharmaceutical API manufacturing operation or a regulated environment is desirable.

For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / marcel@sigmar.ie

 

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