Quality Engineer

AbbVie•North Chicago, IL

19d

About The Position

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 . 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.

Requirements

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.

Responsibilities

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.