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CSV Engineer

  1. Ireland, Cork
Dundalk
  1. Contract
Competitive
  1. Compliance / Quality Assurance
37144
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CSV Engineer - Ireland, Dundalk - 12 Months Contract 

Do you want to be involved with exciting pharmaceutical projects?

When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a CSV Engineer.

Essential Duties and Responsibilities for this role include, but are not limited to, the following:
  • Analytical and microbiological method validations or Computer system validations.
  • Planning and Design Qualification (URS, FRS, FAT, SAT) and Commissioning
  • Risk Assessments (e.g. FMEA)
  • Installation-, Operational- and Performance Qualification
  • Documents for regulatory purposes
  • Support root cause analyses and troubleshooting activities in case of deviations from Qualife
  • ication/Validation PerspectivLead and participate in Risk Analysis of equipment, systems and processes
  • Planning and execution of Computerised Systems Validation (CSV) in cooperation with IT and Process Automation
Desirable Experience:
  • Prior experience with quality systems is an advantage.
  • Kneat and EVAL software is highly advantageous.
  • Extensive professional experience in pharmaceutical Industry.
  • Exceptional knowledge in the areas of qualification and validation of building, utilities, equipment, manufacturing processes and analytical and microbiological methods.
  • Knowledge in automation and computer system validation.
  • Project management knowledge, leadership capabilities with respect to quality topics.
  • Experience with implementation of new pharmaceutical buildings and new line preferred.
If this role is of interest to you, please apply now!
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