Process Engineer – PFS

About the job

To provide Process Engineering support to existing business as usual daily functions and on-going continuous improvement pre filled syringe processes across both commercial lines. Support in the manufacturing of monoclonal antibody (mAb) commercial products, support technology transfer of new products, support introduction of capacity enablers and to work as part of a highly focused and integrated Engineering Team in a Sterile Manufacturing environment.

About Sanofi Business Unit

The multiple national award-winning Sanofi Waterford biopharmaceutical and medical device campus is located in Waterford on Ireland’s southeast coast. Established in 2001 and now with more than 800 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.

Main responsibilities:

The main area of work is to provide day shift support on the existing Aseptic Syringe Filling Lines which includes Debagger / Ebeam / Delid / Deline / Isolator / Syringe filling machine with multi filling technologiesExecute Process Engineering activities (cycle development protocol/reports, project improvements, deviations, problem solving, change controls, etc) to schedule and to the appropriate compliance and safety standardsOwn and deliver projects works under the bracket of continuous improvement in the existing thawing, formulation, filling, filter integrity testing and wash/autoclave areas to support NPI and capacity expansion including but not limited to single use technology vendor selection, component introduction and qualificationSupport commercial manufacturing through delivery of key performance metrics (SQDCI)

About you ​

Degree in an Engineering disciplineStrong problem solving skillsStrong documentation/protocol generation and execution skillsSignificant experience in a highly regulated GMP environmentExperience of Sterile Manufacturing OperationsExperience in syringe filling would be a distinct advantage.

Beneficial but not Essential

Cleaning verification/validation experienceExperience with various forms of filtration and associated filter integrity testingAutoclave & Parts washer knowledgeExperience in sterile manufacturing

Why choose us?

Working with state of the art technologyIntroducing new products to siteProcess ownership of projects start to finishSupporting commercial manufacturing to provide patients with products

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.

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