Senior Transformation Qualification Lead

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

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