NPI Process Scientist

4 months ago

Sligo, Ireland TEAM HORIZON Full time
Description

Team Horizon is seeking a NPI Process Scientist for our client based in Sligo. The NPI Process Scientist provides operational technical support for process related issues and has strong problem-solving abilities with an ability to work under pressure. The individual will work cross-functionally and be able to lead projects to deliver process improvements and cost savings.



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 product.
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 manufacturing.
Preparation and updating of specification related to NPA materials and consumables.
Leading and / or assisting risk assessment (e.g., PFMEA, EHS).
Developing NPI related documents e.g., Transfer Plans/Protocols/Manufacturing Batch Records.
Working closely with global science and quality teams, on the process development of suitable future products.
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.

What you need to apply:



Third level degree in a relevant engineering, science, or technology discipline. 
Masters qualification in a relevant technical discipline is desirable.
Minimum of 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 is essential.

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