NPI Process Scientist

Desired Skills: lyophilization,NPI,tech transfer

The role:

PE Global is currently recruiting for an NPI Process Scientist on behalf of a leading biologics company in Sligo. This is an initial 12 month contract role.

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.
• 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.

Education and Experience:

• Third level degree in a relevant engineering, science or technical discipline required.
• Masters 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.
• Minimum of 1 years in a similar type of role.
• Minimum of 1 years within Pharmaceutical or Bio Industries.
• Strong technical and operational knowledge of unit operation within a fill finish facility

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***