We're currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Waterford. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do

Job Description

To provide Process Engineering support to existing business as usual daily functions and on-going continuous improvement pre filled syringe processes across both commercial lines. Support in the manufacturing of monoclonal antibody (mAb) commercial products, support technology transfer of new products, support introduction of capacity enablers and to work as part of a highly focused and integrated Engineering Team in a Sterile Manufacturing environment.

Main Responsibilities

• The main area of work is to provide day shift support on the existing Aseptic Syringe Filling Lines which includes Debagger / Ebeam / Delid / Deline / Isolator / Syringe filling machine with multi filling technologies
• Execute Process Engineering activities (cycle development protocol/reports, project improvements, deviations, problem solving, change controls, etc) to schedule and to the appropriate compliance and safety standards
• Own and deliver projects works under the bracket of continuous improvement in the existing thawing, formulation, filling, filter integrity testing and wash/autoclave areas to support NPI and capacity expansion including but not limited to single use technology vendor selection, component introduction and qualification
• Support commercial manufacturing through delivery of key performance metrics (SQDCI)

About You

• Degree in an Engineering discipline
• Strong problem solving skills
• Strong documentation/protocol generation and execution skills
• Significant experience in a highly regulated GMP environment
• Experience of Sterile Manufacturing Operations
• Experience in syringe filling would be a distinct advantage.

Beneficial But Not Essential

• Cleaning verification/validation experience
• Experience with various forms of filtration and associated filter integrity testing
• Autoclave & Parts washer knowledge
• Experience in sterile manufacturing
  
  

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