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Associate Director, Commissioning and Start-Up Engineering
North Chicago, Illinois, United States · On-site
$142k–$269k/yr
Senior+
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 r…
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 r…
Skills: Validation, Commissioning, Qualification, Risk management, Computer system validation
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 r…
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 r…
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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 r…
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 r…
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$59k–$104k/yr
Full-time
bachelor degree
Paid time off, Medical insurance, Dental insurance, Vision insurance, 401(k), Short-term incentive programs
Posted 3d ago
Apply by Aug 18
~40 hrs/week
Responsibilities
The associate engineer is responsible for applying engineering knowledge to complete technical assignments while ensuring compliance with quality, safety, and regulatory standards. They facilitate project scope definition, manage concurrent tasks, and coordinate with cross-functional teams to support equipment qualification and process improvements.
Requirements
Candidates must hold a bachelor's degree in an engineering discipline and possess 0-2 years of relevant experience in a GMP manufacturing environment. Proficiency in engineering principles, regulatory requirements, and technical documentation is essential for success in this role.
Full job description
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
An engineering/analyst professional who applies engineering and/or scientific knowledge, mathematics, and ingenuity to complete basic assignments related to a specific technical field or discipline.
Responsibilities
Responsible for compliance with applicable regulations and standards for Quality; Environment, Health, and Safety (EH&S) Global Policies; AbbVie Engineering Standards; and other governance areas as applicable. Identifies areas of risk with respect to compliance. Assists in development and revision of procedures and standards
Facilitates the definition of a project scope with stakeholders. Converts goals to tasks and steps. Within structure, plans own work, manages several, often concurrent, tasks to accomplish assigned tasks to meet or exceed expectations (cost, quality, time). Participates in basic economic analysis and feasibility studies related to project alternatives under guidance. Jointly responsible for achieving the project’s financial targets in support of business objectives.
Plans and conducts small-sized assigned projects requiring conventional types of plans, investigations, and/or equipment. Implements plans; initiates execution of own work plan; monitors executions for adherence to plan, e.g. documents work status and reports to management with appropriate frequency. Coordinates with Quality Assurance / Validation / Engineering /technical support personnel to conduct qualification activities (EFU qualification / cleaning validation), prototype or experimental ru
Assists in the training of personnel required for the operation of facilities, processes, and equipment. Establishes contacts with supervisor, project leaders and other professionals in group.
Keep aware of the changing technical and competitive environment as it relates to the business and share with co-workers. Participates and/or assists other team members in the design of products/processes/equipment/systems/ facilities by applying standard engineering/science theories, concepts, and techniques within the discipline. Investigates, conducts tests, gathers data, performs preliminary analysis, report findings, and prepares and communicates recommendations and respective action plans
Interprets problems and either creates or modifies design solutions. Reviews existing layouts and standards and creates a proposed design. Applies standard engineering/science principles and methodologies to interpret, draw conclusions and recommend solutions for problems considering a broad range of factors. Improves methods/designs/processes. Recognizes and implements innovations and cost reductions.
Builds relationships, initiates and cultivates open, honest relationships with colleagues, customers, contractors, and vendors by establishing rapport, developing an understanding of others’ needs, promoting common goals, and following through on commitments.
Conveys information effectively through verbal, written, and presentations to stakeholders and team members, both internal and external to AbbVie, using appropriate communication protocols. Identifies ways to increase customer satisfaction. Documents agreements and commitments and keeps direct customers informed throughout the project or initiative.
Qualifications
Bachelor’s degree in Mechanical, Chemical, Electrical, Process, Biomedical, or a related Engineering discipline.
0-2 years engineering experience preferably within the pharmaceutical, biopharmaceutical or other GMP manufacturing environment.
Basic understanding of biopharmaceutical manufacturing processes, including upstream/downstream operations, clean utilities, HVAC, cleanrooms, and process equipment.
Knowledge of cGMP regulations and regulatory requirements, including FDA, EMA, and data integrity expectations.
Familiarity with project engineering principles, including capital project execution, equipment installation, commissioning, and startup support.
Understanding of Commissioning, Qualification, and Validation (CQV), including development and execution of IQ/OQ/PQ protocols and validation documentation.
Knowledge of process equipment and/or utility systems, including Clean-in-Place (CIP), Steam-in-Place (SIP), Purified Water (PW), Water for Injection (WFI), clean steam, compressed gases, and process instrumentation.
Strong technical problem-solving skills with the ability to perform root cause analysis, risk assessments, and support CAPA implementation.
Excellent communication and collaboration skills, with the ability to work effectively across cross-functional and global engineering teams.
Commitment to continuous improvement using Lean Manufacturing, Six Sigma, and engineering best practices to optimize reliability and operational efficiency.
Proficiency in Microsoft Office and familiarity with engineering systems such as SAP, CMMS, AutoCAD, and project management tools in a GMP-regulated environment.
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 roleat the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors 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 isearned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that areallocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolutediscretion, 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.
EngineeringPharmaceuticalBiopharmaceuticalGMPManufacturingQuality AssuranceValidationCQVIQ/OQ/PQClean-in-PlaceSteam-in-PlaceHVACCleanroomsRoot Cause AnalysisCAPALean Manufacturing
Allergan is now part of AbbVie.
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at www.abbvie.com. Follow @AbbVie on LinkedIn for future updates.
Offices: Allergan plc, Dublin, Coolock D17 E400, IE · Morris Corporate Center III, 400 Interpace Parkway, Parsippany, NJ 07054, US · Parkway, Marlow, England SL7 1YL, GB · 301 W Howard Ln, Austin, TX 78753, US · 8301 Mars Dr, Hewitt, TX 76712, US
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