Process Engineer MFFL
Process Engineer MFFL
- Location: Waterford
- Salary: €50-60 p/h
- Job Type: Full-time, Contract
About Sanofi Business Unit
The multiple national award-winning Sanofi Waterford biopharmaceutical and medical device campus is in Waterford on Ireland's southeast coast.
Established in 2001 and now with more than 700 employees, the site has seen more than €600m invested in state-of-the-art infrastructure and technology. Diversification continues to bring new products to Waterford and the expanded site portfolio continues to create new opportunities.
At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds, and experiences.
We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients, and customers.
In this role you will:
- 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.
- Investigate/trouble shoot and solution implement on process and equipment deviations using GPS3 problem solving tools.
- Monitor 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.
- 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 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 regulatory.
- Experience with change control, deviation management and associated compliance activities and systems.
Apply today or contact myself at [email protected] for further information.