Senior Manager, Utilities - Durham, NC
About The Position
AbbVie is recruiting a Senior Manager, Utilities for its new manufacturing campus in Durham, North Carolina. The campus will combine advanced manufacturing, laboratory technologies, and AI to support production of immunology, oncology, and neuroscience medicines. The role provides technical leadership and subject matter expertise for critical and clean utility systems, including Water for Injection (WFI), clean steam, process gases, and related generation, storage, distribution, monitoring, and control systems. It also leads technical workstreams, process improvement and optimization, validation and troubleshooting, and the development of technical standards and documentation. The Senior Manager will lead utility design reviews and provide operational input through project execution, with attention to safe and reliable operation, maintainability, capacity, redundancy, energy efficiency, lifecycle cost, and future manufacturing needs. The position also provides leadership for process waste systems, including waste inactivation, neutralization, and equalization. The role leads 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. Following turnover, the role establishes and manages the utilities operating organization, including procedures, preventive maintenance, personnel training and qualification, staffing, operating metrics, alarm response, monitoring, and day-to-day operations. It partners with Engineering, Manufacturing, Quality, Validation, EHS, Automation, and Maintenance to sustain safe, compliant, reliable system performance and drive lifecycle improvements. Travel is 50% of the time.
Requirements
- Bachelor's degree in Engineering or a similar related discipline.
- 8 or more years of relevant industry experience.
- Experience in drug substance, drug product, biologics, and/or aseptic sterile fill-finish is required.
- 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 actionable methods and analyses, collaborating with cross-functional partners, and advising on complex technical decisions and risks.
- Design site-level processes and improvements by defining operating ranges, critical parameters, and acceptance criteria to support efficient, high-quality production.
- Lead process improvement and optimization workstreams, define the technical approach, 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.
- Establish technical standards for process documentation and change execution, ensuring methods, assumptions, and evidence are complete.
- Guide engineers through technical decisions, facilitate working sessions, document decision logic, and track actions to closure.
- Deliver technical outputs for complex projects and programs, validate methods, document results and assumptions, ensure adherence to applicable standards and controls, and communicate progress, impacts, and recommended mitigations.
- 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 systems.
- Lead utilities design reviews and provide operational input throughout project execution, considering safety, reliability, maintainability, capacity, redundancy, energy efficiency, lifecycle cost, and future manufacturing requirements.
- Provide technical and operational leadership for process waste systems, including waste inactivation, neutralization, and equalization systems.
- 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, staff training and qualification, staffing plans, operating metrics, alarm response, system monitoring, and day-to-day operations.
- Partner with Engineering, Manufacturing, Quality, Validation, EHS, Automation, and Maintenance to manage system performance, deviations, change control, reliability improvements, capacity planning, and continuous improvement throughout the asset lifecycle.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
