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Process Engineer

  1. Midlands (Ireland)
Carlow
  1. Contract
Competitive
  1. Life Sciences
34901wr
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Process Engineer - Tech Transfer/NPI - Carlow/Hybrid 2-3 days on site - 11-Months 

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 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 qualification/validation documentation and process development studies in line with the standard approval process. 
  • Design/Author/Review/Approve/Execute Execution/development of change controls. 
  • Contribution to Kaizen events as appropriate 
  • Technical input into quality notification by authoring/reviewing/approving investigations 
  • Execution of equipment/qualification validation programs; including re-qualification and re-validation 
  • Support continuous improvement through Lean Six Sigma methodologies. 
  • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues. 
  • Serve as technical engineering representative for internal technical group discussions and represent technical Operations Carlow at global technical forums. 
  • Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
  • Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance. 
  • Work collaboratively to drive a safe and compliant culture in Carlow. 
  • May be required to perform other duties as assigned. 


Skills and Knowledge:
  • Bachelor’s Degree or higher preferred; ideally in a Science, Engineering, or other Technical discipline 
  • Min 3 years’ experience ideally in manufacturing, preferably GMP Setting 
  • Demonstrable experience of leading technical related projects 
  • Evidence of continuous professional development is desirable. 
  • Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable but not a necessity. 
  • Knowledge of regulatory/code 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. 
  • 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, please apply now for immediate consideration and further information.

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