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AbbVie NPI Process Engineer in Sligo, Ireland

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X (https://twitter.com/abbvieireland) , Facebook, Instagram (https://www.instagram.com/abbvieireland/) , YouTube and LinkedIn.

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.

Additional Information

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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