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Employer Collins Mcnicholas Recruitment
Job Title CSV Engineer- Leitrim

Our client, a leading Medical Device company in Leitrim, is looking to hire a CSV Engineer.


  • Required knowledge of GAMP.
  • Completion of software risk assessments
  • Knowledge and understanding of reading/generating IUS (Intended use statements), URS (User Requirements specifications), FS (Functional Specifications).
  • Completion of Requirements Traceability Records.
  • Generating Software Master Validation Plans, Software IQ’s, OQ’s, and PQ’s.
  • Participation in the new product introductions programmes to ensure that they are effectively introduced in accordance with the requirements of ISO 13845, in regard to software applications.
  • Maintenance of the plant software master plan

  • Degree in Quality or Technical with emphasis on Medical Device Industry
  • Computer Systems Validation experience
  • Ideally 2-3 yrs experience in medical device or pharma industry
For a confidential discussion and a more detailed job description, please contact Mark Whelan on 071 914 2411 or email,

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This job originally appeared on
Location Leitrim
Date Added 13 days ago
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