Global Process Engineer (Aseptic)

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.
• 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
• Good knowledge of:
• 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
• 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.

Requirements

• 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
• Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.
• AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
• US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
• US & Puerto Rico

Benefits

Additional Information

Purpose 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.

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