Transformation Project Qualification Lead- API

AbbVie Inc.; North Chicago (IL); On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie is seeking a Transformation Project Qualification Lead to spearhead EFU and Automation Qualification on a Strategic Capital Project. You will drive schedule, execution, risk management, and reporting for the teams, partnering with project owners and engineers to ensure compliant commissioning and validation.

We value a strong background in manufacturing/quality within healthcare or pharma, plus experience leading cross-functional teams and delivering high-quality, regulator-ready

Qualifications

• Bachelor’s Degree in Engineering, science, or closely related discipline; 3+ years in engineering/operational work.
• Experience developing commissioning, qualification, validation deliverables and risk management documentation.
• 6+ years in Manufacturing, Quality or Engineering with 4 major validation subjects (e.g., Computer, Equipment, Cleaning, Process).
• Technical background in healthcare, pharmaceutical, or related industries preferred.

Responsibilities

• Develop User Requirements Specifications and Functional/Design Specifications for new or modified equipment, facilities, and utilities.
• Support Factory Acceptance Testing with Project Engineer to confirm unit acceptance.
• Identify risk controls, critical elements and traceability of equipment design based on FMEA or other risk assessment.
• Develop and execute commissioning, qualification and validation test protocols to ensure unit functionality per specs.
• Perform minor troubleshooting during commissioning and document unresolved issues.
• May supervise project resources and support training of maintenance/technical staff.

Skills

Risk management

FMEA

Project leadership

Quality/compliance

Cross-functional collaboration

Communication skills

Education

Bachelor’s Degree in Engineering, Science, or related

Equivalent technical experience

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

Job Description

The Operations Transformation organization's mission is to accelerate future-ready Operations through purposeful transformation and drive excellence through new technology and enhanced cross-functional collaboration. The Strategic Capital Deployment team leads AbbVie Operations' long-term strategic investments and investment roadmaps, while executing large-scale capital projects through optimized delivery, technology adoption, and cross-functional collaboration.

The Transformation Project Qualification Lead will lead the project EFU and Automation Qualification sub-teams on a Strategic Capital Project. They are accountable to the Project Director and will be responsible for driving the schedule, execution, risk management, and reporting for the teams.

An engineering professional that works with project owners, subject designers/engineers and other project team members to plan, and complete tasks associated with commissioning, qualification and validation of new and modified equipment, facilities, utilities, product, processes etc.in line with project, operations and quality objectives. Level of responsibility and performance is commensurate with grade level. The main objective is to establish evaluation, testing and documentation for risk management, commissioning and validation applying product and regulatory requirements and risk management to result in robust, high quality products. This includes optimizing systems that support the work in and around this area of responsibility.

Responsibilities

• Work with end-user and project engineer to develop User Requirements Specifications and Functional / Design Specifications for new or modified equipment, facilities, and utilities.
• Support Factory Acceptance Testing in conjunction with Project Engineer to confirm unit is acceptable.
• Identify risk controls, critical elements and traceability of equipment design based on FMEA or other risk assessment.
• Develop and execute commissioning, qualification and validation test protocols to ensure that the unit functions according to specifications.
• Perform minor troubleshooting of issues encountered during commissioning and documentation of unresolved issues.
• Able to support broader aspects of projects at times including: project leadership, developing operational procedures, support training of maintenance/technical staff/operators on new equipment, reviewing new or modified product documentation to ensure compatibility with qualified equipment and implementing changes in equipment parameters or recipes.
• Leads Execution of Risk Management. including, periodic review and update per the Validation Master Plan, interface with best practices, establishing team's work practices including overall program, ccRA. Understands risk management principles. Can find and review documentation. Understands controls, impact of change, trace controls, and can estimate ratings using appropriate scale. Timely. Demonstrated success in FMEA authorization/facilitation.
• Qualification as QRM facilitator commensurate with responsibility.
• May supervise contract validation resources in the timely completion of activities in his/her area of responsibility

Qualifications

• Bachelor’s Degree in Engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 3+ years of significant engineering and/or operational experience.
• Experience in the development of commissioning, qualification, validation and risk management deliverables including specifications and testing protocols that can stand up to regulatory scrutiny.
• 6+ years of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred
• A technical background in health care, nutritional products, laboratory diagnostics, medical devices, pharmaceutical, or similar industries (preferred).
• Strong interpersonal, communication, and negotiation skills with demonstrated ability to work within a team environment.
• Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred
• Ability to supervise junior or contract team members (prior supervisory experience preferred)
• Ability to manage complex projects and multiple projects (5+) simultaneously

Additional Information

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.

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