Process Engineer

3 weeks ago

Dublin, Dublin City, Ireland Quanta part of QCS Staffing Full time

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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:
  1. Lead/execute production floor-based activities
  2. Participate on a team of engineers
  3. Plan and execute C&Q, validation activities as required
  4. Design & develop engineering studies
  5. Provide technical input into quality notifications by authoring/reviewing/approving investigations
  6. Execute equipment/qualification validation programs, including re-qualification and re-validation
  7. Perform data analysis and make informed decisions/recommendations based on data analysis
  8. Conduct statistical data analysis to support development and commercialization batches
  9. Support continuous improvement through Lean Six Sigma methodologies
  10. Lead and actively participate in projects, system failure investigations, and report writing
  11. Perform root cause analysis of system failures using standard tools and methods to resolve issues
  12. Participate in and/or lead cross-functional or single-function teams, 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 5 years of related work experience in aseptic manufacturing/process engineering
  • Knowledge of regulatory and core requirements to Irish, European, and international standards and practices
  • Report writing, standards, and policy development skills required
  • Experience with equipment and process validation
  • Knowledge of sterile filling processes and equipment
  • Proficiency in Microsoft Office and related computer applications
  • Lean Six Sigma methodology experience is desirable
  • Excellent communication, presentation, and interpersonal skills for effective teamwork and external interactions

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

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