Global Process Engineer; Aseptic

Job Description

The Global Process Support Engineer (Aseptic) will support the Abb Vie Technical Operations Functions and the Abb Vie 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.

As the Global Process Support Engineer (Aseptic), you will support the Technical Operations Functions and Technical Centers worldwide. Your role will involve advanced scientific knowledge, engineering expertise, mathematics and ingenuity to complete complex assignments related to aseptic capital projects and aseptic process troubleshooting. You will lead change from an engineering perspective, solving operating issues, and providing technical support to cross‑functional teams within the Aseptic sites.

• 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.

MS 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

• Aseptic fill finish technology 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 finish on particular
• Understands both equipment control and SCADA and MES levels.
• Secondary packaging
• Single use systems
• Cleaning and sanitisation methodologies.
• Knowledge about associated technology (Lyophilisation, Blow Fill Seal)
• Application of robotics

• 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.

• 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

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many…