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CSV Engineer - Ireland  

Company managed [?] Still accepting applications

Posted on : 08 May 2017

Project Description

Responsibilities
  • Partner with our project teams in performing Information Systems CSV across a range of projects. 
  • Development and execution of the qualification of Information Technologies 
  • Development of life cycle documents necessary to address the validation life-cycle 
  • Preparation / testing of validation protocols, and all associated documentation for equipment and systems 
  • Review and approval of all Computer Systems / Software Validation Documentation 


Requirements
  • BS or MS in Engineering, Computer Science or IT is preferred 
  • Minimum of 3-5 years’ experience in a pharmaceutical, biotech or medical device environment 
  • Experience with the management, development and/or validation of Information Systems Technology projects – MES, LIMS, Trackwise etc 
  • Prior experience in working with cGMPs and/or GLPs and Quality Systems 
  • Knowledge of FDA and GMP guidelines a must