NPI Process Scientist

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We are looking for an NPI Process Scientist to join our Technical Operations Team in Abbvie, Ballytivnan. This position reports to the NPI Product Lead. The NPI Process Scientist has a high level of autonomy and works on their own initiative to support and execute new product introductions onsite. You will need to have strong relationship building skills and the ability to work collaboratively with peers and cross functional teams to deliver NPI’s successfully.

Roles and Responsibilities

• Work closely with global science and quality teams, on the process development of suitable future products for AbbVie.
• Perform gap analysis, facility fit studies, process safety and risk analysis for New Product Introductions.
• Develop NPI related documents e.g., Transfer Plans/ Protocols/ Procedures/ Manufacturing Batch Records.
• Assist with the development of manufacturing process for new products.
• Prepare and update specifications related to NPI materials and consumables.
• Lead and / or assist risk assessments (e.g., PFMEA, EHS).
• Provide operational technical support for process related issue resolution.
• Monitor and analyse process data during the manufacturing.
• Assist and /or lead product and process related investigation and change plans.
• Support, supervise, and train operations personnel for NPI processes.
• Adhere to and support all EHS&E standards, procedures, and policies.

Qualifications

• Third level degree in science, engineering, or other relevant technical subject area
• Masters qualification in relevant technical field is desirable.
• 4+ years experience in pharmaceutical process engineering with relevant experience of batch processing, new product introductions, technical transfers, scale up in a cGMP pharmaceutical or biologics company.
• Strong technical and operational knowledge of unit operation within an aseptic fill finish facility
• Excellent relationship building skills, with the ability to influence peers and colleagues.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.