Process Engineer - MFFL

Job description

Process Engineer - MFFL

About the Opportunity

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 support 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.

About the Sanofi Business Unit

The Sanofi Waterford biopharmaceutical and medical device campus is located in Waterford on Ireland’s southeast coast. Established in 2001 and now with more than 700 employees, the multiple national award-winning 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. Sanofi is a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

About growing with us

In this role you will….

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Support commercial manufacturing through delivery of key performance metrics (SQDCI) in a fast paced environment

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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

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Investigation/trouble shooting and solution implementation on process and equipment deviations using GPS3 problem solving tools

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Monitoring and review of equipment cycle trends using PI application

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Assist in the implementation of capital projects

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Implement and monitor performance metrics

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Lead technical problem resolution & RCA (Root Cause Analysis) for all manufacturing operations, in conjunction with cross functional teams

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Lead cycle time reduction initiatives in conjunction with manufacturing teams

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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

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Provide engineering support to other areas of the MFFL process such as Dispensing, Formulation, Autoclaving and Washing

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Provide technical support to implement process improvements, new product transfers to the site and production

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Design and implement Process development programs through plant trials, execution and change implementation

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Constantly seek to challenge operational standards and driving continuous improvement

About you

To excel in this role you will need to have:-

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Honours degree in an Engineering discipline

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Strong problem solving skills

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3 or more years’ relevant experience in a highly regulated GMP environment

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Experience of Sterile Manufacturing Operations would be an advantage

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Experience in syringe filling would be a distinct advantage

 

In Addition to

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Excellent communication skills

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Strong interpersonal skills

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Strong leadership skills

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Strong Technical Writing skills

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Strong coordination, project management and planning skills

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Customer-focused decision making skills

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Strong understanding of maintenance, reliability, safety, quality and regulatory

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Experience with change control, deviation management and associated compliance activities and systems

Inspire your Journey: what Sanofi can offer you:

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A successor position to Manufacturing or Engineering Team leaders positions on the site

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Opportunity to join team with range of products (pharmaceutical and biological that are marketed globally)

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Involvement in supporting clinical trial programmes and transfer to site of new products and technologies

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A role where you are instrumental to creating best practice and as the organisation grows, you can too

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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

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We have highly subsidised restaurant with free tea and coffee

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A newly refurbished gym is available onsite for a small and highly competitive annual membership fee

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Parking available onsite

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This is a full time role and we support flexible working

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.