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CSV Engineer

Posted on Jul 21, 2020 by Global Rekrut

Cork, Ireland
27 Jul 2020
€60k - €65k Annual

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.
  • Responsible assessing the validation impact of changes made to qualified instruments.
  • Other duties as assigned.

Skills & Experience Required:

  • Good verbal and written communication skills.
  • 5+ years' experience in Bio-Pharmaceutical or equivalent type life science industry.
  • Good organizational skills.
  • Must have good interpersonal skills. Position will require a good deal of interdepartmental interaction and coordination.
  • 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.
  • Must have ability to comprehend technical information related to computer software, computer and network hardware, and the associated regulatory requirements relating to them.
  • Experience/Knowledge in qualifying DeltaV, OSI PI, Serialisation changes.
  • Proficiency with MS Office applications (Word, Excel, Visio, Access, Project, Powerpoint).
  • Experience with HP ALM or equivalent software testing/requirements tools.

Education Required:

  • Computer Science or Engineering/Science Degree is preferred.

*If this role could be of your interest, please submit your CV for immediate consideration. For any questions do not hesitate to contact us*

Reference: 914363756

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