Process Engineer

  • Waterford
  • Sanofi
About the jobTo provide Process Engineering shift support to existing business as usual daily functions and on-going continuous improvement prefilled syringe processes. 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 Waterford:Main responsibilities:The main area of work is to own and deliver batch release related activity to support the PFS Fill and Inspection Operations - such as investigations, Root cause analysis, CAPA generation and closure, work order investigations and addressing batch comments from the quality team.In addition, supporting 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 qualification.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.Other responsibilities will be to provide support on the existing Aseptic Syringe Filling Line which includes Debagger / Ebeam / Delid / Deline / Isolator / Syringe filling machine with multi filling technologies.Support commercial manufacturing through delivery of key performance metrics (SQDCI).About youEssential requirements: 1+ more years’ relevant of experience in a highly regulated GMP environmentDegree in an Engineering disciplineStrong problem solving and communication skillsStrong documentation/protocol generation and execution skillsBeneficial but not Essential:Batch release experienceRoot cause analysis and Investigation exposureExperience in syringe/vial filling & inspection would be a distinct advantageExperience in sterile manufacturingWhat we offerA role where you are instrumental to creating best practice and as the organisation grows, you can tooWe offer a generous package including flexible benefits, and are committed to helping you have a healthy work-life balance throughout your career with usWe have highly subsidised restaurant with free tea and coffeeA newly refurbished gym is available onsite for a small and highly competitive annual membership feeParking available onsiteWe support flexible workingOpportunity to work with state of the art technology and grow in commercial manufacturing environment (batch release within a GMP facility) to provide patients with productsIf the description fits your experience and has aroused your interest, please apply so we can get in contact with you! 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.Pursue . Discover .#LI-EURPursue , discover 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, ability or gender identity.Watch our and check out our Diversity Equity and Inclusion actions at !