NPI Process Engineer/Scientist


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https://www.teamhorizon.ie/job-search/909-npi-process-engineer/scientist/engineering/sligo/job2023-03-29 12:55:521970-01-01Team Horizon
Job TypePermanent
LocationSligo
AreaSligo, IrelandSligoIrelandSligo
SectorEngineeringLaboratory/Scientific
Start Date
AdvertiserDarcy Ainscough-Denton
Telephone+353 1 574 6266
Job Ref1002879
Job Views156
Description
Team Horizon is seeking a NPI Process Engineer/Scientist (Aseptic Fill Finish) for our client who are a global leader in the biopharmaceutical industry. The role will support the client’s oncology-focused sterile manufacturing facility. The NPI team is part of Technical Operations and is responsible for the technology transfer of innovative new biologic products from R&D and external partners.

The NPI group works cross-functionally with the wider site team and the client’s global network to successfully onboard biologics products, and we are looking for a talented professional with a solid technical background who can collaborate effectively and work to defined timelines on exciting projects.

 

Why you should apply:


  • This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.


  • There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.


  • Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.


 

What you will be doing:


  • Assisting in the development of the manufacturing process for new products.


  • Providing operational technical support for process related issue resolution.


  • Performing gap analysis, facility fit studies, process safety and risk analysis for NPI.


  • Monitoring and analysis of process data during the manufacturing.


  • Preparation and updating of specifications related to NPI materials and consumables.


  • Lead and / or assist risk assessments (e.g., PFMEA, EHS).


  • Development of NPI related documents e.g., Transfer Plans/Protocols/Procedures/Manufacturing Batch Records.


  • Working closely with global science and quality teams, on the process development of suitable future products for the client.


  • Assisting and /or leading product and process related investigation and change plans.


  • Supporting, supervising, and training operations personnel for NPI processes.


  • Adheres to and supports all EHS&E standards, procedures, and policies.


  • Any other duties as assigned.


 

What you need to apply:


  • Third level degree in a relevant engineering, science or technical discipline required.


  • Master’s Qualification in relevant technical discipline desirable.


  • 3 years’ experience in pharmaceutical process engineering, with relevant experience of batch processing, technical transfers, scale up, in a cGMP pharmaceutical or Biologics industry.


  • Experience in new product introductions to Biologic facilities desirable.


 

 
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