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Process Engineer

  1. West
Carlow
  1. Contract
Competitive
  1. CAPEX Projects
34949
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Process Engineer - Pharmaceuticals - 11-Month Contract

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

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:
  • Lead/execute production floor-based activities.
  • Plan and execute C&Q, validation activities as required.
  • Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support.
  • Provide technical input into quality notification by authoring/reviewing/approving investigations.
  • Execution of equipment/qualification validation programs; including re-qualification and re-validation
  • Design/Author/Review/Approve/Execute 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.
  • Statistical data analysis to support development and commercialisation batches.
  • 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
  • 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 

Requirements:
  • Prior related work experience; ideally in manufacturing, preferably GMP Setting
  • Typically have 5 years related work experience in Aseptic manufacturing / process engineering.
  • Equipment and process validation
  • Sterile filling processes and equipment
  • Lean Six Sigma Methodology experience desired.

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

 #LI-CH3
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