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CSV Engineer

  1. Ireland, Dublin
Dublin
  1. Contract
Competitive
  1. Life Sciences
37744
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CSV Engineer - Ireland, North Dublin - 12 Months Initial 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:
  • Manufacturing Processes
  • Analytical and microbiological method validations o Computer system validations SpecificallyDevelop, Review and Execution of project related documentation against current GMP-requirements such as (but not limited to):
  • Planning and Design Qualification (URS, FRS, FAT, SAT) and Commissioning
  • Risk Assessments (e.g. FMEA)
  • Installation-, Operational- and Performance Qualification
  • Documents for regulatory purposes
  • Assessments
  • Change controls, Deviations etc.
  • Planning and execution of Computerised Systems Validation (CSV) in cooperation with IT and Process Automation
  • Lead and participate in Risk Analysis of equipment, systems and processes
  • Issue Formal Commissioning and Qualification Plans, Protocols and Reports and support different Equipment and Systems owners by providing technical knowledge
  • Apply professional interdisciplinary project teamwork supporting the team with Engineering department, Qualification Department, Production, EHS in questions regarding GMP-compliant solutions
  • Support root cause analyses and troubleshooting activities in case of deviations from Qualification/Validation Perspective
  • Support creation, assessment, and completion of change control cases from Qualification/Validation Perspective.
  • Contact to the overall project leaders in different departments and within the global project team to support project execution
Desirable Experience:
  • Kneat and EVAL software is highly advantageous
  • Requires 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
  • Strong soft skills for the coordination and motivation of interdisciplinary teams in a matrix structure
  • Exceptional degree of team spirit, flexibility and robustness
  • Qualification activities not related to the project.
If this role is of interest to you, please apply now!

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