Process Engineer

Summary:
Our client is a global bio pharma company based in Waterford seeking a Process Engineer who will be responsible for the qualification of new equipment into commercial manufacturing.

Responsibilities:

• 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.

Qualifications & Experience:

• Honours degree in an Engineering discipline.
• 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.
• Strong leadership skills.
• Strong Technical Writing skills.
• Strong coordination, project management and planning skills.
• Strong understanding of maintenance, reliability, safety, quality and regulatory.
• Experience with change control, deviation management and associated compliance activities and systems.