Description:
We are looking for an NPI Process Scientist to join our Technical Operations team in Ballytivnan. 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.
Roles And Responsibilities
- 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.
- Lead and / or assist risk assessment (e.g., PFMEA, EHS).
- Development of 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 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 technology discipline
- Masters qualification in a relevant technical discipline is 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 is desirable