NPI Process Engineer

2701 - NPI Process Engineer

We are currently recruiting and seeking applications for an experienced NPI Process Engineer to join our clients’ expanding team in Sligo.

As an NPI Process Engineer or Scientist, you will work cross-functionally with other teams and global network to successfully onboard biologics products, and we are looking for talented people with a solid technical background who are good collaborators and communicators capable of working to defined timelines on exciting projects.

Why you should apply:

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  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.


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  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.


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  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:

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


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  Providing operational technical support for process related issue resolution.


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


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  Monitoring and analysis of process data during the manufacturing.


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


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


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


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


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


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  Supporting, supervising, and training operations personnel for NPI processes


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

 

What you need to apply:

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


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  Masters Qualification in relevant technical discipline desirable.


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


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  Experience in new product introductions to Biologic facilities desirable.