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Contact Info
Sean McCarthy
Life Science

+3530212339371
[email protected]
Connect with me on
Program Manager
Westmeath
QA Specialist
Limerick
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Details

CSV Engineer - Permanent or Contract Available


Reference:SMC02317 Location: Cork
Qualification:DegreeExperience:See description
Job Type:PermanentSalary: Not Disclosed
May be suitable for: EHS Engineer, Validation Specialist



Role Responsibilities

  • Develops and executes all validation deliverables including execution for:
  • Automation Projects – OSI PI upgrade / Integrations, Versiondog Upgrade
  • MFG/QC Instruments
  • Capable of owning issues/deviations and driving them to resolution.
  • Leading testing efforts for small to medium sized projects.
  • Reviewing vendor protocols, test scripts, and traceability matrix.
  • Capable of generating test scripts to meet the user requirements.
  • Interacts directly with project teams and the associated vendors.


Skills & Experience Required

  • Experience in Bio-Pharmaceutical or equivalent life science industry.
  • Must possess a thorough understanding of GxPs, in addition to FDA and International requirements for computer validation and Part 11 / Annex 11 requirements.
  • Must possess a thorough understanding of current industry guidance, including GAMP 5
  • Must have direct experience with computer validation and determining computer validation approach.
  • Experience/Knowledge in qualifying DeltaV, OSI PI, Serialisation changes.
  • Experience with HP ALM or equivalent software testing/requirements tools.
  • Computer Science or Engineering/Science Degree is preferred.



If you would like further Information you can contact the recruiter directly:

Sean McCarthy | Tel: +353 (0) 87 798 8480

PLEASE APPLY DIRECTLY BY CLICKING HERE

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