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Quality Engineer

AbbVie North Chicago, Illinois, United States

onsitefull-time
Posted Jan 21, 2026Apply by Feb 20, 2026

Role & seniority: Associate/Support role in Validation and Manufacturing Quality Assurance (2+ years related experience)

Stack/tools: Quality System management, CAPA, SOPs, calibration requests, product/process qualification, statistical quality programs, acceptance sampling

Top 3 responsibilities

  1. Assist Validation Engineer in validation/certification of new process equipment; periodically review certified systems

  2. Implement and maintain the Quality System; ensure regulatory compliance and quality goals

  3. Investigate plant events, perform product impact analyses, place QA holds as needed; document in CAPA system; participate in Validation Review Board

Must-have skills

  • Bachelor’s in Biology, Chemistry, Engineering, or related field; 2+ years in Manufacturing, Quality, or Engineering

  • Strong written/verbal communication; problem solving and analytical ability

  • Interpersonal and negotiation skills; knowledge of quality/compliance standards for API/Bulk Drug/Finished goods

Nice-to-haves

  • Experience with CAPA systems, regulatory inspections, and statistical quality programs

  • Familiarity with calibration activities and SOP approval processes

  • Location & work type: US or Puerto Rico-based; full-time position with eligible benefits and incentive programs

Full Description

Company 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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Responsibilities

Job Description

In this role, an individual supports Validation Engineers by assisting with the validation and certification processes for new equipment, and by periodically reviewing existing systems to ensure ongoing quality compliance. They help maintain and implement the company's Quality System, ensuring all activities and procedures align with company standards and regulatory requirements. The person also assists in investigating plant events, performing product impact analyses, and managing product holds when needed.

Assist Validation Engineer in the validation and certification of all new process equipment and periodically review all certified systems to assure the capability of meeting quality requirements. Responsible for implementing and maintaining the effectiveness of the Quality System. Support to ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations. Ensures investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Performs product impact analyses for plant events and places product on QA hold where appropriate. Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments. Participates on the Validation Review Board as the Manufacturing Quality Assurance function. Approves standard operating procedures; ensures procedures comply with policy and make sense. Approves calibration requests and ensures that these requests have appropriate product/process limits assigned. Develop and implement statistical quality programs, assure all acceptance sampling is capable of meeting expected product quality confidence levels for manufactured as well as purchased materials.

Qualifications

Bachelor's degree, preferably in Biology, Chemistry or Engineering or equivalent related experience 2+ years of overall experience in Manufacturing, Quality or Engineering Good verbal and written communication skills. Good problem solving and analytical skills Good interpersonal relations / communications skills Good negotiation skills Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.

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 ofthis posting 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 short-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 anybonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's soleand absolute discretion unless and until 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

Quality ComplianceValidationAnalytical SkillsProblem SolvingInterpersonal SkillsCommunication SkillsNegotiation SkillsStatistical Quality ProgramsManufacturingEngineeringRegulatory RequirementsStandard Operating ProceduresCalibration RequestsProduct Impact AnalysisCAPA SystemQuality Systemmulti-location

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