Transformation Project Qualification Lead
About the job
- A bachelor's degree in Engineering, science, or a closely related discipline is desired, or equivalent technical experience plus demonstrated competence.
- Desired 3+ years of significant engineering and/or operational experience.
- Experience developing commissioning, qualification, validation, and risk management deliverables, including specifications and testing protocols that can withstand regulatory scrutiny.
- 6+ years of overall experience in Manufacturing, Quality, or Engineering, including four major validation subjects, is preferred.
- A technical background in health care, nutritional products, laboratory diagnostics, medical devices, pharmaceutical, or similar industries is preferred.
- Knowledge of quality and compliance management, and regulations and standards affecting API, Bulk Drug, or Finished goods manufacturing, is preferred.
- Ability to supervise junior or contract team members; prior supervisory experience is preferred.
- Ability to manage complex projects and five or more projects simultaneously.
- Strong interpersonal, communication, and negotiation skills and ability to work within a team environment.
- Lead the project EFU and Automation Qualification sub-teams on a Strategic Capital Project, driving their schedule, execution, risk management, and reporting while being accountable to the Project Director.
- Plan and complete tasks associated with commissioning, qualification, and validation of new and modified equipment, facilities, utilities, products, and processes in line with project, operations, and quality objectives.
- Establish evaluation, testing, and documentation for risk management, commissioning, and validation using product and regulatory requirements and risk management to deliver robust, high-quality products; optimize systems supporting this work.
- Work with end users and project engineers to develop User Requirements Specifications and Functional or Design Specifications for new or modified equipment, facilities, and utilities.
- Support Factory Acceptance Testing with the Project Engineer to confirm equipment is acceptable.
- Identify risk controls, critical elements, and traceability of equipment design using Failure Mode and Effects Analysis or other risk assessments.
- Develop and execute commissioning, qualification, and validation test protocols to ensure equipment functions according to specifications.
- Perform minor troubleshooting during commissioning and document unresolved issues.
- Support broader project activities as needed, including project leadership; developing operational procedures; supporting training of maintenance, technical staff, and operators on new equipment; reviewing new or modified product documentation for compatibility with qualified equipment; and implementing changes in equipment parameters or recipes.
- Lead execution of risk management, including periodic review and updates in accordance with the Validation Master Plan, interfacing with best practices, and establishing team work practices, including the overall program and ccRA.
- Apply risk management principles; find and review documentation; understand controls, change impacts, and trace controls; estimate ratings using the appropriate scale; and act in a timely manner.
- Facilitate Failure Mode and Effects Analysis successfully and hold QRM facilitator qualification commensurate with responsibility.
- May supervise contract validation resources to ensure timely completion of activities in the area of responsibility.
About the company
AbbVie is a global biopharmaceutical company that develops and sells medicines to treat serious health conditions. Its portfolio spans immunology, oncology, virology, neuroscience, and aesthetics, with products designed to modulate the immune system, target disease pathways, or support medical aesthetics. AbbVie compounds its products through a heavy emphasis on research and development, investing billions to build a steady pipeline of new therapies. Its medicines are brought to market by selling to healthcare providers, hospitals, and clinics, and in some cases directly to patients via prescriptions. The company differentiates itself through a wide, globally distributed product line, substantial R&D investment, and a commitment to sustainability and patient care, including science-based targets. AbbVie’s goal is to improve patient outcomes by delivering effective treatments for unmet medical needs while pursuing long-term, responsible growth across healthcare markets.
Company Size
10,001+
Company Stage
IPO
Headquarters
North Chicago, Illinois
Founded
1888
Get referred to AbbVie
See people who can refer or advise you
Simplify's Take
What believers are saying
- Apogee acquisition closed in 2026, expanding AbbVie’s immunology pipeline beyond Skyrizi and Rinvoq.
- EU approvals for RINVOQ and EPKINLY in September 2026 broaden ex-U.S. revenue.
- JUVMO launches in October 2026, adding a fresh neuroscience revenue line.
What critics are saying
- Humira, Skyrizi, and Rinvoq concentration keeps AbbVie exposed if immunology growth slows in 2027.
- Niaspan antitrust MDL and Biocell ALCL settlements carried $1.7 billion litigation accrual by June 2026.
- Generic ubrogepant and atogepant suits threaten Ubrelvy and Qulipta exclusivity within years.
What makes AbbVie unique
- Skyrizi and Rinvoq anchor AbbVie’s post-Humira immunology franchise across 11 EU RINVOQ indications.
- JUVMO’s September 28, 2026 FDA approval gives AbbVie first-in-class Parkinson’s D1/D5 therapy.
- AbbVie pairs blockbuster cash flows with Apogee, Iambic, and Valkai deal-making.
Help us improve and share your feedback! Did you find this helpful?
Benefits
- Remote Work Options
- Flexible Work Hours
- Professional Development Budget