Process Engineer

Sanofi

Waterford
Permanent
Full-time

21 hours ago

Process Engineer

Location: Waterford
Job type: FTC – day role, no shift

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: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.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 environment
Degree in an Engineering discipline
Strong problem solving and communication skills
Strong documentation/protocol generation and execution skills

Beneficial but not Essential:

Batch release experience
Root cause analysis and Investigation exposure
Experience in syringe/vial filling & inspection would be a distinct advantage
Experience in sterile manufacturing

What we offer

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
We support flexible working
Opportunity to work with state of the art technology and grow in commercial manufacturing environment (batch release within a GMP facility) to provide patients with products

If the description fits your experience and has aroused your interest, please apply so we can get in contact with you!Discover our , that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document, before applying.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 Progress. Discover Extraordinary.#LI-EURPursue progress, discover extraordinaryBetter 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 !

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