Senior Process Engineer

4 days ago

Dublin, Dublin City, Ireland TN Ireland Full time

Job Summary

TN Ireland is seeking a highly skilled Process Engineer to join their team in Ireland. As a key member of the manufacturing operations team, you will be responsible for leading and executing production floor-based activities.

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

Key Responsibilities
  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 notification by authoring/reviewing/approving investigations
  6. Execution of equipment/qualification validation programs; including re-qualification and re-validation
  7. Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis
  8. Statistical data analysis to support development and commercialisation batches
  9. Support continuous improvement through Lean Six Sigma methodologies
  10. Leading and active participation in projects, system failure investigations and investigation reports
  11. Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues
  12. Participate and/or lead cross-functional or single-function teams including liaising with vendors or above site groups
Requirements
  1. Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other technical discipline
  2. Prior related work experience; ideally in manufacturing, preferably GMP Setting
  3. Typically have 5 years related work experience in Aseptic manufacturing / process engineering
  4. Knowledge of regulatory/core requirements to Irish, European and International Codes, Standards and Practices
  5. Report, standards, policy writing skills required
  6. Equipment and process validation
  7. Sterile filling processes and equipment
  8. Proficiency in Microsoft Office and job-related computer applications required
  9. Lean Six Sigma Methodology experience desired
  10. Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team-oriented manner

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