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  • DUBLIN 2
  • Job reference number:15449980
  • Client ID:RI/AM16788
  • Posted on:07-JUN-2019
  • Location:WATERFORD
  • Job type:PERMANENT

Process Engineer (Sterile) - County Waterford.

In this role you will provide engineering support to the sterile fill-finish function, in the design, commissioning and qualification of equipment and processes to facilitate the manufacture of new and existing products.

Core Responsibilities:
• Provide engineering support to Sterile Fill-Finish development teams and projects
• Develop and support new manufacturing processes and technologies
• Understand equipment operation in detail
• Define and review equipment specification and associated test documentation.
• Support project delivery through FAT, SAT and IOQ involvement as needed
• Troubleshoot equipment issues with particular emphasis on process cycles (e.g. cleaning, sterilizing)
• Identify means to improve processes, increase efficiencies and reduce costs
• Strong focus on disciplined root cause analysis
• Liaise with vendors on disposable technology and integration into the process
• Development of process cleaning and sterilization cycles
• Development of critical process parameters for the process and development of process capability and deviation monitoring
• Monitor process risk and ensure mitigations are in place as required
• Benchmark other industries and organisations to ensure best practice is in use.

Interested applicants should have:

Minimum of degree level in engineering or related discipline
Minimum 1 year's Process Engineering experience within a relevant Pharma environment (preferably within a sterile manufacturing environment)

Ability to understand engineering processes through a logical, data driven, hands on approach
Use of FMEA, FMECA and Risk assessment techniques

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