Senior Manager, Utilities - Durham, NC

Military Spouse Corporate Career Network•Durham, NC

2d•Onsite

About The Position

AbbVie is establishing a new manufacturing campus in Durham, North Carolina, to expand medicine production. The campus will integrate advanced manufacturing, laboratory technologies, and AI, and will include manufacturing facilities, laboratories, a warehouse, administrative offices, and employee wellness facilities. The Senior Manager, Utilities will provide technical and operational leadership for critical and clean utility systems and process waste systems, and will lead their design, start-up, commissioning, qualification, and ongoing operation.

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 through actionable methods and analyses, cross-functional collaboration, and advice on complex technical decisions and risks.
Design site-level processes and improvements, defining operating ranges, critical parameters, and acceptance criteria to support efficient, high-quality production.
Lead process improvement and optimization workstreams, define 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 running working sessions, documenting decision logic, and tracking actions to completion.
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 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 Water for Injection (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, addressing safe and reliable operation, 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, ensuring integration with manufacturing processes, environmental requirements, and site infrastructure.
Lead start-up, commissioning, and qualification of utility and waste systems, including system turnover strategies, commissioning plans, acceptance testing, qualification activities, punch-list resolution, and transition to site operations.
Establish and manage the utilities operating organization following system turnover, including procedures, preventive maintenance strategies, personnel training and qualification, staffing plans, operating metrics, alarm response, system monitoring, and day-to-day operations.
Ensure safe, compliant, and reliable utility-system performance in partnership with Engineering, Manufacturing, Quality, Validation, EHS, Automation, and Maintenance, managing system performance, deviations, change control, reliability improvements, capacity planning, and continuous improvement throughout the asset lifecycle.