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Graduate Systems Engineer 45k

Job description

CSV ENGINEER

My client based in the Munster region is looking to recruit a :

Computer Systems Validation Engineer 

Minimal experience is required. 12 Months experience & upwards required.


The activities would include:
• Development & execution of the qualification of Information Technologies.

  • Development and execution of qualification & validation of Information Systems software.
  • Generation, execution, review & approval of IOQ protocols and associated validation documents.
  • Prepares/reviews validation documentation related to projects/change controls
  • Manages change controls and other compliance related tasks e.g. non-conformances
  • Participates in the review of current and future CSV procedures and polices
  • Analyzes the results of testing & determines the acceptability of results against predetermined criteria.
  • Completion of CSV deliverables including 21CFR11 Assessments, Annex 11 Assessments.
  • Generation, Review and Approval of User Requirement Specifications, Functional Specifications etc..
  • Installation and Set up of Lab Systems / IPT Equipment.
  • Installation and Operation Qualification Protocol Generation, Execution and Reporting for Lab Systems.
  • Ensure from a CSV perspective to ensure their continued validated/qualified state.
  • Ensure that appropriate Site Validation Listing is established and controlled.
  • Review/Approval of all Computer Systems/Software Validation Documentation.

What you'll need !

Bachelor’s degree in Computer Science, Computer Engineering, etc..

  •  12 months to 2 years experience in this area. 

For further info please call Colin on 021-4315770 or E-mail me codonnell@sigmar.ie

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