Process Engineer

Our client is looking for a Process Engineer to join their team as a contractor

Location: Waterford
Salary: €50 -60 per hour

The Client:
Our client is a leading biologics company who has continued to grow and diversify to serve patients around the world. Their site in Waterford comprises of almost 800 employees who work together at a state of the art biopharmaceutical and medical device campus.


The Team:
To provide Process Engineering support to existing business as usual daily functions and on-going continuous improvement pre filled syringe processes. 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:

• Support Qualification of new equipment into commercial manufacturing
• 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.
• Investigation/trouble shooting and solution implementation on process and equipment deviations using GPS3 problem solving tools
• Monitoring and review of equipment cycle trends using PI application
• Assist in the implementation of capital projects
• Implement and monitor performance metrics.
• Lead technical problem resolution & RCA (Root Cause Analysis) for all manufacturing operations, in conjunction with cross functional teams.
• Lead cycle time reduction initiatives in conjunction with manufacturing teams
• The main area of work would be on the Aseptic Syringe Filling Line which includes Debagger / Ebeam / Delid / Deline / Isolator / Syringe filling machine with multi filling technologies.
• Lead Process Engineering tech transfer activities for product introduction / transfer to the MFFL Line.
• Provide engineering support to other areas of the MFFL process such as Dispensing, Formulation, Autoclaving and Washing.
• Provide technical support to implement process improvements, new product transfers to the site and production.
• Design and implement Process development programs through plant trials, execution and change implementation
• Constantly seek to challenge operational standards and driving continuous improvement.

Skills and Experience Required

• Honours degree in an Engineering discipline
• Strong problem solving skills
• 3 or more years' relevant experience in a highly regulated GMP environment.Experience of Sterile Manufacturing Operations would be an advantage.
• Experience in syringe filling would be a distinct advantage.

** Please note in order to be considered for this role all applicants should have valid right to work status to work in irealnd at time of application***

If you feel that this role would be of interest to you please reach out to Elidyah at [email protected]