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