NPI Process Engineer

AbbVie

Sligo, Ireland

Job Description

We are looking for an NPI Process Engineer, to join our Tech Ops team on our site in Ballytivnan site in Sligo. This is a new role due to expansion at the site. Reporting to the NPI Technical Manager, The NPI Process Engineer will handle NPI and tech transfer into the biologics fill finish facility. They will also assist in the development of the manufacturing process for new products.

Roles and Responsibilities:

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 AbbVie;
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.

Qualifications

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.

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