Process Engineer Contract

Process Engineer – Carlow – Contract

Excellent Carlow based role – this position will suit someone with at least 3 years experienec ideally with Pharmaceutical GMP experienec supporting Operations.

The new team member will serve as technical support for new product introduction (NPI) and commercial manufacturing.

Role Functions

  1. Lead/execute production floor-based activities
  2. Participate on a team of engineers
  3. Plan and execute validation activities as required
  4. Design & develop engineering studies
  5. Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support
  6. Provide technical input into quality notification by authoring/reviewing/approving investigations
  7. Execution of equipment/qualification validation programs; including re-qualification and re-validation
  8. Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process
  9. Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis
  10. Statistical data analysis to support development and commercialisation batches
  11. Support continuous improvement through Lean Six Sigma methodologies
  12. Leading and active participation in projects, system failure investigations and investigation reports
  13. Execution/development of change controls
  14. Contribution to Kaizen events as appropriate
  15. Perform root cause analysis of system failures.
  16. Implement subsequent corrective action through the change management system
  17. Serve as technical engineering representative for internal technical group discussions
  18. Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups

Experience, Knowledge & Skills

• 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 3 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,

Qualifications & Education

Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other technical discipline

To apply for this job email your details to rachel@rtlanerecruitment.ie.