An exciting opportunity has arisen with our Client, a biologics company based in Waterford for a Process Engineer to provide support to the Multi Format Filling Line (MFFL) line for the aseptic processing of monoclonal antibody (mAb) commercial products. The incumbent will support technology transfer of new products and work as part of a highly focused and integrated Engineering Team in a Sterile Manufacturing environment.
- 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.
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 coordination, project management and planning skills.
- Customer-focused decision making skills.
- Strong understanding of maintenance, reliability, safety, quality and regulatory.
- Experience with change control, deviation management and associated compliance activities and systems.
To apply for this job email your details to firstname.lastname@example.org.