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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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