NPI Scientist/Engineer

at  AbbVie

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, Facebook, Instagram, YouTube and LinkedIn.
Job Description
We have an exciting new opportunity for an experienced NPI Scientist/ Engineer to join our site in Dublin. This is a 12-month fixed term contract. The successful candidate will have technical ownership of new product introductions to the site spanning developmental studies and clinical manufacturing up to validation and post-commercialization changes.

QUALIFICATIONS

• Bachelors or Masters degree in Chemical Engineering, Analytical Chemistry or Pharmacy or equivalent discipline.
• 1-3 years relevant OSD experience; or equivalent combination of education and experience.
• Experience working with pharmaceutical processing technologies and good understanding of 21CFR / cGMP documentation and electronic systems requirements.
• Technical expertise in the pharmaceutical technology and automated control systems
• Highly motivated, agile, and flexible, with a high sense of urgency
• Proactive problem-solving mindset always prepares solutions for unexpected situations.
• Team player who works collaboratively with regional and global colleagues
• Excellent written and spoken English language skills, particularly in presenting and authoring technical presentations and reports.
• Excellent communication skills with the ability to present in global meetings as well as face-to-face with senior leadership.
  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

• Serve as site representative on a new product introduction team, ensuring that production concerns and recommendations are factored into late-stage product development to optimise manufacturing processes and ensure the site’s ability to consistently supply the new product in the production environment.
• Execute the validation strategy for the new product being transferred or existing product being enhanced, including providing recommendations for batch sizes against forecast and performing and maintaining risk assessments.
• Manage the generation of all production batch procedural documentation, such as project change controls, change notices, risk assessment reports, process validation protocols and reports, new batch manufacturing records.
• Prepare and execute feasibility, NDA, pre-validation and validation protocols and reports that enable first time right execution of manufacturing process.
• Provide continuous oversight with a hands-on mentality on product performance, periodic reviews with senior leadership.
• Lead investigations of process deviations with a high sense of urgency to quantify the potential impact on product quality.