Global Process Engineer (Aseptic)

AbbVie • North Chicago, IL

1d • Onsite

About The Position

The Global Process Support Engineer (Aseptic) will support the AbbVie Technical Operations Functions and the AbbVie Technical Centers worldwide. This position 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.

Requirements

• MS or PHD in Mechanical, Chemical Engineering or related field
• 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
• Good knowledge of: Aseptic fill finish technology and suppliers
• Good knowledge of: Broader compounding, built infrastructure (cleanroom design, services (water, HVAC…..)
• Good knowledge of: Knowledge of regulatory environment and requirements both in Europe and the US
• Good knowledge of: Methods of Microbial control and environmental monitoring
• Good knowledge of: Control and information systems used in secondary pharma and fill finish on particular
• Good knowledge of: Understands both equipment control and SCADA and MES levels.
• Good knowledge of: Secondary packaging
• Good knowledge of: Single use systems
• Good knowledge of: Cleaning and sanitisation methodologies.
• Good knowledge of: Knowledge about associated technology (Lyophilisation, Blow Fill Seal)
• Good knowledge of: Application of robotics
• Understanding of: typical process analysis and troubleshooting tools.
• Understanding of: high containment processing
• Understanding of: change control requirements
• Understanding of: key literature beyond regulations (ISPE, AMSE, ISO, USP)
• Understanding of: project costing, lead times, control and management
• Understanding of: broader commercial environment in the Pharma industry.
• Demonstrated excellence in breadth and depth of knowledge within the aseptic 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

Responsibilities

• Serves as organization spokesperson on advanced projects and/or programs related to aseptic operation 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 timely project completion.
• May act as lead engineer, project leader, or project contributor.
• Ensures quality and effectiveness of aseptic solutions as part of major projects through sound design, early risk assessments, and implementation strategies.
• Has full awareness of the potential consequences (defects and failure modes) of design changes to established processes.
• 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.
• Responsible for compliance with applicable corporate and local policies and procedures.

Benefits

• comprehensive package of benefits including paid time off (vacation, holidays, sick)
• medical/dental/vision insurance
• 401(k)
• eligible to participate in our long-term incentive programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior