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Process Engineer

  1. East
Carlow
  1. Contract
Competitive
  1. CAPEX Projects
10-05-2024
31084
Process Engineer - Contract - Ireland 

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 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. 


Essential Duties and Responsibilities for this role include, but are not limited to, the following:
  • Lead/execute production floor-based activities
  • Participate on a team of engineers
  • Plan and execute C&Q, validation activities as required
  • Design & develop engineering studies
  • Provide technical input into quality notification by authoring/reviewing/approving investigations
  • Execution of equipment/qualification validation programs; including re-qualification and re-validation
  • 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
  • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues
  • Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups

Requirements:
  • Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other technical discipline
  • Prior related work experience; ideally in manufacturing, preferably GMP Setting
  • Typically have 5 years related work experience in Aseptic manufacturing / process engineering
  • Knowledge of regulatory/core 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
  • Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner

If you are interested initially, please apply now for immediate consideration and further information.

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