Global Process Engineer - Biologics

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

The Global Biologics upstream and downstream Process Engineer will support the AbbVie Technical Operations Functions and the AbbVie Technical Centers worldwide. This position, working with little or no supervision, will be responsible for applying advanced scientific knowledge, engineering knowledge, mathematics, and ingenuity to complete complex assignments related to biologics capital projects and biologics 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.

Good knowledge of

- Pharmaceutical biotechnology and suppliers
- Broader compounding, built infrastructure (cleanroom design, services (water, HVAC…..)
- Knowledge of regulatory environment and requirements both in Europe and the US
- Methods of Microbial control and environmental monitoring
- Control and information systems used in secondary pharma and fill finishing on particular
- Understands both equipment control and SCADA and MES levels.
- Single use systems
- Cleaning and sanitization methodologies.
- Application of robotics

Understanding of

- typical process analysis and troubleshooting tools.
- high containment processing
- change control requirements
- key literature beyond regulations (ISPE, AMSE, ISO, USP)
- project costing, lead times, control and management
- broader commercial environment in the Pharma industry.

Responsibilities

Identifies biologics equipment for multi-million capital projects working across engineering disciplines, including specifying and purchasing equipment.; Serves as organization spokesperson on advanced projects and/or programs related to pharmaceutical biotechnology including equipment selection. Presents results of projects both internally and externally.; Acts as advisor to management and operating sites on applications of new advanced processing equipment and participates in project planning, process update; Responsible for compliance with applicable corporate policies and procedures. Ensures quality and effectiveness of solutions as part of major projects through sound design, early risk assessments, and implementation of strategies. Has full awareness of the potential consequences (defects and failure modes) of design changes to established processes.; May act as lead engineer, project leader, or project contributor.; Evaluates and integrate relevant engineering advances for improving or solving problems. Understands the business implications of assigned products and processes and identify engineering solutions compatible with business needs.; Provides technical direction and feedback to others.

Requirements

Bachelor’s degree in chemical or mechanical engineering.; MS or PHD in Chemical Engineering or related field is preferred.; Minimum 5+ years of significant engineering in pharmaceutical aseptic process design, equipment selection and operation in one of the following areas: upstream and downstream biological processing.; Has demonstrated excellence in breadth and depth of knowledge within the biological equipment area and is recognized as a subject matter expert.; Experience in specifying and purchasing upstream and downstream process equipment as a subject matter expert; Demonstrated excellence in breadth and depth of knowledge within the pharmaceutical biotechnology discipline and is recognized as a subject matter expert; Experience active participating or leading FMEA, Risk Assessments and/or Investigations for aseptic pharmaceutical processes.; Must demonstrate negotiation skills and ability to reconcile differences; Experience in a corporate engineering group environment is preferred