This is 12 month contract with a view to extension
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.
• 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.
• 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.
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