Global Process Engineer - Biologics

About the role

The Global Biologics upstream and downstream Process Engineer supports AbbVie Technical Operations Functions and AbbVie Technical Centers worldwide. This position involves applying advanced scientific knowledge, engineering knowledge, mathematics, and ingenuity to complete complex assignments related to biologics capital projects and process troubleshooting. The role requires contributing to the development of new principles and concepts and leading change from an engineering perspective.

Responsibilities

• Identifies biologics equipment for multi-million dollar capital projects, working across engineering disciplines, including specifying and purchasing equipment.
• Serves as the organization spokesperson on advanced projects and programs related to pharmaceutical biotechnology, including equipment selection. Presents results of projects both internally and externally.
• Acts as an advisor to management and operating sites on applications of new advanced processing equipment and participates in project planning, process updates.
• 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 of design changes to established processes.
• May act as lead engineer, project leader, or project contributor.
• Provides technical direction and feedback to others.

Qualifications

• 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 upstream and downstream biological processing.
• Demonstrated excellence in breadth and depth of knowledge within the biological equipment area and recognized as a subject matter expert.
• Experience in specifying and purchasing upstream and downstream process equipment as a subject matter expert.
• Good knowledge of:
• Pharmaceutical biotechnology and suppliers
• Broadly compounded, built infrastructure (cleanroom design, services)
• 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
• Understandings 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.
• Experience:
• Demonstrated excellence in breadth and depth of knowledge within the pharmaceutical biotechnology discipline and recognized as a subject matter expert.
• Experience actively 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.

Pay

$124,500 - $236,500 USD