Global Process Engineer (Aseptic)

Global Process Engineer (Aseptic)

AbbVie

Cork, Ireland

Job Description

We are looking for a Global Process Support Engineer (Aseptic) to support the AbbVie Technical Operations Functions and AbbVie Technical Centers worldwide. The successful candidate will be responsible for applying advanced scientific knowledge, engineering knowledge, mathematics, and ingenuity to complete complex assignments related to aseptic capital projects and aseptic process troubleshooting. The selected candidate will contribute to the development of new principles and concepts, and is expected to lead change from an engineering perspective. Will also be responsible for solving operating issues and providing technical support to cross-functional teams within the Aseptic sites.

Role and Responsibilities

• Serve as organization spokesperson on advanced projects and/or programs related to aseptic operation including equipment selection. Presents results of projects both internally and externally;
• Act as advisor to management and operating sites on applications of new advanced processing equipment and participates in project planning, process update;
• Responsible for timely project completion;
• May act as lead engineer, project leader, or project contributor;
• Ensure quality and effectiveness of aseptic solutions as part of major projects through sound design, early risk assessments, and implementation strategies. Full awareness of the potential consequences (defects and failure modes) of design changes to established processes;
• Evaluate and integrate relevant engineering advances for improving or solving problems;
• Understand the business implications of assigned products and processes and identify engineering solutions compatible with business needs;
• Provide technical direction and feedback to others;
• Comply with applicable corporate and local policies and procedures.

Qualifications

• Masters or PhD in Mechanical, Chemical Engineering or related field with 6 to 8 years of engineering experience in pharmaceutical aseptic process design, equipment selection and operation in one of the following areas: general aseptic processing; upstream and downstream biological processing; aseptic fill finishing;
• Demonstrated excellence in breadth and depth of knowledge within the aseptic discipline and is recognized as a subject matter expert;
• Broader compounding, built infrastructure (cleanroom design, services (water, HVAC…..);
• Experience of actively participating or leading FMEA, Risk Assessments and/or Investigations for aseptic pharmaceutical processes;
• Good negotiation skills and ability to reconcile difference;
• Knowledge of regulatory environment and requirements both in Europe and the US;
• Experience in a corporate engineering group environment is preferred.