- A new vacancy has arisen for a Process Engineer (MFFL) at our client’s busy pharmaceutical site in Co. Waterford.
- The successful candidate will provide support to the Multi Format Filling Line (MFFL) line for the aseptic processing of monoclonal antibody (mAb) commercial products.
- The Process Engineer will support technology transfer of new products and work as part of a highly focused and integrated Engineering Team in a Sterile Manufacturing environment.
Core Duties and 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.
Qualifications and Experience:
- 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.
- Excellent communication and interpersonal skills.
- Strong Technical Writing, 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: Quote – PE22110
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, R95 F727, Ireland.
+353 56 77 90100
Please note, we do not require agency assistance with this role.