NPI Process Scientist

We are working with a pharmaceutical client in Sligo to recruit a NPI Process Scientist to join their team on a temporary, 12 month contract.

Responsibilities:

• 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.

Requirements:

• Third-level degree in a relevant engineering, science, or technical discipline required.
• Master's qualification in a relevant technical discipline desirable.
• Minimum 3 years' experience in pharmaceutical process engineering, including batch processing, technical transfers, and scale-up within a cGMP pharmaceutical or biologics environment.
• Minimum 1 year's experience in a similar rolewithin the pharmaceutical or biologics industry.