Global Process Engineer (Aseptic)

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.

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.

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Qualifications :

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.

Experience:

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

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• 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 thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand we may ultimately pay more or less than the posted range. This range may be modified in the future. 

• 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. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commissionincentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless anduntil paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.

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  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

No

Employment Type :

Full-time