Global Process Engineer (Aseptic)

BioSpace; North Chicago (IL); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a Global Process Support Engineer (Aseptic) to support Technical Operations worldwide. You will apply advanced engineering to aseptic capital projects, lead change from an engineering perspective, and provide cross-functional technical support across sites.

This role demands deep expertise in aseptic processing and project leadership. The candidate will oversee design, risk assessments, and implementation strategies while navigating regulatory environments in Europe and the US.

Qualifications

• MS or PhD in Mechanical, Chemical Engineering or related field.
• 6 to 8 years of engineering experience in pharmaceutical aseptic process design and equipment selection.

Responsibilities

• Serve as organization spokesperson on aseptic projects and programs.
• Advise management on applications of new processing equipment and participate in project planning.
• Ensure timely project completion and quality of aseptic solutions.

Skills

Aseptic processing knowledge

Project leadership

Risk assessments

Cross-functional collaboration

Education

MS or PhD in Mechanical or Chemical Engineering

Tools

SCADA

MES

Regulatory compliance

Job description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

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.

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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof thisposting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission,incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless anduntil paid andmay bemodifiedat the Companys sole and absolute discretion, consistent withapplicable 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, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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

https://www.abbvie.com/join-us/reasonable-accommodations.html