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CSV Engineer - Permanent or Contract Available

Reference:SMC02317
Location: Cork
Qualification:Degree
Experience:See description
Job Type:Permanent
Salary:Not Disclosed
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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

Under the Data Protection Acts 1988 and 2003, your details will be kept confidential and will not be passed to a third party without your express prior consent.

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