Global Process Engineer (Aseptic)

Posted Yesterday
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North Chicago, IL, USA
Hybrid
125K-237K Annually
Senior level
Healthtech • Pharmaceutical
The Role
Supports global pharmaceutical technical operations through aseptic process design, equipment selection, troubleshooting, capital project leadership, risk assessment, and implementation of advanced manufacturing technologies. Advises sites and management, leads engineering changes, evaluates equipment and process improvements, supports compliance, and provides technical direction for aseptic fill-finish, biological processing, cleanroom infrastructure, automation, and contamination control initiatives.
Summary Generated by Built In
Company Description

About AbbVie

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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

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

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 location,and 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, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company’s 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 https://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

Skills Required

  • MS or PhD in Mechanical Engineering, Chemical Engineering, or a related field
  • 6 to 8 years of engineering experience in pharmaceutical aseptic process design, equipment selection, and operation
  • Experience in general aseptic processing, upstream or downstream biological processing, or aseptic fill-finish
  • Knowledge of aseptic fill-finish technology and suppliers
  • Knowledge of compounding, cleanroom design, water systems, and HVAC infrastructure
  • Knowledge of pharmaceutical regulatory requirements in Europe and the United States
  • Knowledge of microbial control and environmental monitoring
  • Knowledge of control systems, SCADA, and MES used in pharmaceutical and fill-finish operations
  • Knowledge of secondary packaging, single-use systems, cleaning and sanitization, lyophilization, Blow-Fill-Seal, and robotics
  • Understanding of process analysis and troubleshooting tools, high-containment processing, change control, industry standards, and project costing
  • Demonstrated subject matter expertise in aseptic pharmaceutical processes
  • Experience leading or actively participating in FMEA, risk assessments, or aseptic process investigations
  • Negotiation skills and ability to reconcile differences

AbbVie Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AbbVie and has not been reviewed or approved by AbbVie.

  • Retirement Support Retirement programs are portrayed as a standout, with a dollar‑for‑dollar 401(k) match up to 6% and an additional annual company contribution based on age and service. Feedback suggests this materially boosts perceived total compensation for many U.S. employees.
  • Parental & Family Support Paid parental and caregiver leave are emphasized, including up to 12 weeks of fully paid parental leave for all parents and 4 weeks of paid caregiver leave in the U.S. Feedback suggests these policies are a meaningful differentiator for employees balancing family needs.
  • Leave & Time Off Breadth Time off is described as extensive, with tiered vacation that scales with tenure, 17 company holidays, and two paid volunteer days in the U.S. Feedback suggests the breadth of leave contributes notably to overall benefits satisfaction.

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The Company
HQ: North Chicago, IL
56,000 Employees
Year Founded: 2013

What We Do

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.

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