2023-858 – Process Engineer – Waterford Contractor

This is 12 month contract with a view to extension

Purpose

You will support the technology transfer of new products and work as part of a highly focused and integrated Engineering Team in a Sterile Manufacturing environment.

Responibilities

• Support Qualification of new equipment for 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/troubleshooting and solution implementation on process and equipment deviations using GPS3 problem solving tools.

• Monitoring and review of equipment cycle trends using the 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 multifilling 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 drive continuous improvement.

Requirements

• Honours degree in an Engineering discipline.

• Strong problem-solving skills.

• 3 or more years’ relevant experience in a highly regulated GMP environment.

• Experience in Sterile Manufacturing Operations would be an advantage.

• Experience in syringe filling would be a distinct advantage.

• Excellent communication skills.

• Strong interpersonal skills.

• Strong leadership skills.

• Strong Technical Writing skills

• Strong coordination, project management, and planning skills.

• Customer-focused decision-making skills.

• Strong understanding of maintenance, reliability, safety, quality, and regulations.

• Experience with change control, deviation management and associated compliance activities and systems.