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Process Simulation Technical Engineer

  1. West
  1. Contract
Competitive
  1. Life Sciences
14-09-2023
32128
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Process Simulation Technical Engineer - Pharmaceuticals - Carlow 

With worldwide demand for their life-changing oncology treatment increasing; one of our global pharmaceutical clients is looking for a Process Simulation Technical 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:
  • 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 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 investigations
  • reports,
  • Execution/development of change controls to support the Process Simulation process.
Requirements:
  • 3 - 5 year’s operations experience in a sterile manufacturing environment, preferably with Aseptic Process Simulations execution. 
  • Demonstrated ability to coach and lead change.
  • Strong Knowledge of Sterile Manufacturing Processes with a focus on delivery and results within highly regulated controlled environment
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
  • 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, please apply now for immediate response! 

The candidate must have the rights to work in the location stated in the job advert.

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