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CSV Engineer

Location: Cork
Experience:1-2 Years
Job Type:Fixed Term Contract
Salary:Not Disclosed
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May be suitable for: EHS Engineer, Validation Specialist

We’re currently recruiting for an exciting opportunity with an award winning Biotechnology organization based in Cork. This is an excellent opportunity for anyone looking to join a leading multinational who are one of the best at what they do.

Role Summary

The person will participate in the development of custom programs, as well as configurable off the shelf (COTS) systems. Duties include ongoing evaluation and periodic review of existing validated computer systems; change control. Other responsibilities of this position include: generation and execution of validation deliverables and SDLC documents.

Role Responsibilities

  • Develops and executes all validation deliverables including execution for the following projects:
    • Packaging Projects – Serialisation Upgrade on secondary packaging line
    • Automation Projects – DeltaV upgrade, OSI PI mods, Integrations, Virtual Environments

  • Capable of owning issues/deviations and driving them to resolution.
  • Capable leading testing efforts for small to medium sized projects.
  • Capable of 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.
  • Other duties as assigned.

  • Responsible for assessing the validation impact of changes made to the qualified instruments.

Education Required

  • Minimum of a Computer Science or Engineering/Science Degree. Proficiency with minimum 5+ years’ experience in Bio-Pharmaceutical or equivalent type life science industry.

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

Sean McCarthy | Tel: +353 (0) 87 7988480