Senior Manager, Utilities
About The Position
AbbVie is recruiting a Senior Manager, Utilities for its new manufacturing campus in Durham, North Carolina. The campus will include manufacturing facilities, laboratories, a warehouse, administrative offices, and employee wellness facilities, and will support production of medicines in immunology, oncology, and neuroscience. The role provides technical and operational leadership for critical and clean utility systems—including Water for Injection (WFI), clean steam, process gases, and their generation, storage, distribution, monitoring, and control—as well as process waste systems. The Senior Manager leads utility and waste system design input, commissioning, qualification, transition to site operations, and ongoing operation. The position also leads technical workstreams and process improvement, validation, troubleshooting, documentation, and collaboration across project and site functions to support safe, compliant, reliable, and efficient manufacturing.
Requirements
- Bachelor’s degree in Engineering or a similar related discipline.
- Eight or more years of relevant industry experience.
- Experience in drug substance, drug product, biologics, and/or aseptic sterile fill-finish.
- Demonstrated ability to partner cross-functionally with successful teams in a GMP manufacturing environment.
Nice To Haves
- Prior experience in a start-up facility.
Responsibilities
- Lead technical workstreams and contribute to program outcomes by developing methods and analyses, collaborating cross-functionally, and advising on complex technical decisions and risks.
- Design site-level processes and improvements by defining operating ranges, critical parameters, and acceptance criteria for efficient, high-quality production.
- Lead process improvement and optimization workstreams, establish technical approaches, coordinate trials with production, and document results.
- Conduct process validation and troubleshooting by analyzing performance data, investigating deviations, and drafting corrective actions and supporting documentation for review and approval.
- Establish technical standards for process documentation and change execution, ensuring methods, assumptions, and evidence are complete.
- Guide engineers through technical decisions by facilitating working sessions, documenting decision logic, and tracking actions to closure.
- Deliver technical outputs for complex projects and programs; define and validate methods, document results and assumptions, ensure adherence to standards and controls, and communicate progress, impacts, and mitigations to project leads and stakeholders.
- Provide technical leadership and subject matter expertise for the design and implementation of critical and clean utility systems, including WFI, clean steam, process gases, and associated generation, storage, distribution, monitoring, and control systems.
- Lead utilities design reviews and provide operational input throughout project execution, considering safe and reliable operation, maintainability, capacity, redundancy, energy efficiency, lifecycle cost, and future manufacturing needs.
- Provide technical and operational leadership for process waste systems, including waste inactivation, neutralization, and equalization, ensuring integration with manufacturing processes, environmental requirements, and site infrastructure.
- Lead start-up, commissioning, and qualification of utility and waste systems, including turnover strategies, commissioning plans, acceptance testing, qualification activities, punch-list resolution, and transition to site operations.
- Establish and manage the utilities operating organization after system turnover, including procedures, preventive maintenance strategies, personnel training and qualification, staffing plans, operating metrics, alarm response, monitoring, and daily operations.
- Ensure sustained safe, compliant, and reliable utility system performance, partnering with Engineering, Manufacturing, Quality, Validation, EHS, Automation, and Maintenance on system performance, deviations, change control, reliability, capacity planning, and continuous improvement throughout the asset lifecycle.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligible to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
