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CSV Engineer

Job description

My client a WORLD LEADER in delivering digital transformation solutions to Life Science is looking for a CSV Engineer to join their growing team.

Job Responsibilities

  • Manage CSV projects from software install to business release.
  • Generate CSV validation documentation.
  • Liaise with service providers insuring configuration and successful installation.
  • Execute test scrips and analyse test results.
  • Work to identify and implement procedural controls to mitigate issues.
  • Initiate and implement change control with QS and practices.
  • Determine improvements/recommendations for changes.

 

Job Requirements

  • 3+ years’ experience validating IT applications.
  • Proven experience engaging business users ensuring communication and business needs are clearly defined.
  • Experience working in Win 10 environment with server and workstation knowledge.
  • Familiar with Annex 11/21CFR Part 11 requirements, GAMP 5 and data integrity guidelines.
  • Self- motivated with a drive to identify improvements.
  • Experience analyzing and challenging s/w to identify gaps.
  • IT qualification an advantage but not required.

 

For a confidential discussion on this or any other current job opportunity please contact Meggan Tully  on 021 484 144 / MTully@sigmar.ie

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