For more than 20 years, our Waterford team has continued to grow and diversify to serve patients around the world. Today, a team of almost 800 work together at a state-of-the-art biopharmaceutical and medical device campus. Recognised through multiple local and national awards, Sanofi Waterford offers flexible working and access to a world of opportunities to grow your career at one location. As well as attractive benefits, the team enjoy access to an onsite gym and medical centre that underpin a strong commitment to health and wellbeing.
About the job
As a Process Engineer you will provide support to the Multi Format Filling Line (MFFL) line for the aseptic processing of monoclonal antibody (mAb) commercial products. You will the Qualification, Cycle Development and Technology transfer of new products and work as part of a highly focused and integrated Engineering Team in a Sterile Manufacturing environment.
This role will transition from a days position to a shift Process Engineering position as process equipment transitions through design into Commissioning, Qualification and BAU operations.
· Support commercial manufacturing through delivery of key performance metrics (SQDCI) in a fast paced environment
· 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
· 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
· Engineering discipline Degree
· Strong problem solving skills
· 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
In Addition to
· 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
What Sanofi can offer you:
· A successor position to Manufacturing or Engineering Team leaders positions on the site
· Opportunity to join team with range of products (pharmaceutical and biological that are marketed globally)
· Involvement in supporting clinical trial programmes and transfer to site of new products and technologies
· A role where you are instrumental to creating best practice and as the organisation grows, you can too
· We offer a generous package including flexible benefits, and are committed to helping you have a healthy work-life balance throughout your career with us
· We have highly subsidised restaurant with free tea and coffee
· A newly refurbished gym is available onsite for a small and highly competitive annual membership fee
· Parking available onsite
· This is a full time role and we support flexible working
Pursue progress, discover extraordinary.
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. 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 colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.