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Shift Process Engineer

  1. Midlands (Ireland)
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
23-02-2024
32794
Shift Process Engineer - 11 Month Contract + Possible Extensions - Carlow, Ireland 

With worldwide demand for their life-changing oncology treatment increasing; one of our global pharmaceutical clients is looking for a Shift Process Engineer to join their team to support multiple capital projects taking place onsite in Leinster.

This is a fantastic opportunity to work on a state-of-the art fill-finish facility and the company’s first stand-alone vaccine and biologics plant outside the US. 


Role Summary:
  • Design/Author/Review/Approve/Execute process simulations studies in support of new product introduction and ongoing manufacturing support. 
  • Provide technical input into quality notification by authoring/reviewing/approving Process Simulation related investigations. 
  • Design/Author/Review/Approve/Execute commercial & process simulation qualification/validation documentation and studies in line with the standard approval process.
  • Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
  • Support continuous improvement through Lean Six Sigma methodologies.
  • Leading and active participation in projects, system failure investigations and investigation reports, 
  • Execution/development of change controls to support the Process Simulation process. 
  • Contribution to Kaizen events as appropriate. 
  • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why’s etc. 
  • Implement subsequent corrective action through the change management system. 
  • Serve as technical engineering representative for internal technical group discussions and represent technical operations Carlow at global technical forums in relation to process simulations.

Role Requirements: 
  • Bachelor’s Degree or higher preferred; ideally in a Science, Engineering, or other Technical Discipline
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
  • Report, standards, policy writing skills required.
  • Equipment and process validation
  • Sterile filling processes and equipment
  • Proficiency in Microsoft Office and job-related computer applications required.
  • Lean Six Sigma Methodology experience desired.

If this role is of interest to you, please apply now! 
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