Process Engineer - Pharma

https://www.teamhorizon.ie/job-search/1409-process-engineer-pharma/engineering/sligo/job2024-09-03 15:24:162052-01-18Team Horizon
Job TypeContractor
AreaSligo, IrelandSligoIreland
SectorEngineering
Start Date
AdvertiserDavid Connolly
Job Ref1003370
Job Views119
Description

Process Engineer


 


Team Horizon is seeking a Process Engineer for a leading pharmaceutical company in Sligo.


Joining team of 8, reporting to the NPI Technical Manager – team is divided into NPI/Tech Transfer and Manufacturing Support.


Will be based at the Biologics site – parental drug product fill finish facility, supporting design, qualification, and management of single use technologies. Will interact with vendors/manufacturers and review drawings for connectors/filters etc.  Will also work closely with manufacturing, ensuring Operators are trained in single use technologies. Will be involved in investigations/troubleshooting of issues as well as process improvements.


 


Why you should apply:



  • Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.

  • You enjoy working on exciting projects and want to work with a global manufacturing site in Sligo.


 


What you will be doing:



  • Process Engineer for Fill Finish Manufacturing site

  • Leverage detailed understanding of aseptic fill finish manufacturing for design input into equipment commissioning and qualification.

  • Responsible for single use design, onboarding, and qualification.

  • Act as site representative on cross-site teams for standardization of single use assemblies and procedures.

  • Work with supplier technical teams to maintain good relationship.

  • Technical representative on site cross-functional team for design updates and introduction of new single use to site.

  • Author of process flow diagrams for new product introductions / technology transfers.

  • Responsible for aligning PFD between products and standardizing for NPI.

  • Aligns with NPI Lead for product transfer on requirements for new products or process improvements.

  • Technical SME for investigations, responsible for process improvements and monitoring of process efficiency.

  • Author gap assessments, facility fit studies, process safety and risk assessments for NPI.

  • Author scientific reports and technical documentation and presentations to document and communicate project status to internal and external stakeholders.

  • Understand and ensure compliance with safety, regulatory and compliance expectations.

  • Other duties as assigned.


 


What you need to apply:



  • Third level degree in Chemical Engineering, Bioprocess Engineering.

  • 3-5 years’ experience in biopharmaceutical industry.

  • Biologics experience with at scale manufacturing in fill finish facility in a technical role.

  • Experience with new product introductions / technology transfers to fill finish manufacturing facility.

  • Experience in single use technology.

  • Experience in isolator technology.

  • Experience in SAP / Trackwise.

  • Single use Technology: design and qualification in drug product/Fill finish or drug substance is also applicable.

  • Experience dealing with vendors.

  • Operations or design background in single use technology and experience in onboarding single use into a facility.

  • Ability to interact with Operations/Manufacturing on single use training/continuous improvement initiatives.

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