Role Summary
This role is based in Durham, NC. Step into a leadership role where your expertise powers the backbone of our operations. As Senior Manager, Utility Engineering, you’ll ensure the seamless performance of critical site utilities while driving capital projects, innovation and efficiency. This position offers the chance to shape strategic infrastructure plans, mentor a high-performing team, and influence projects that enable life-changing medicines.
Responsibilities
- Lead a team of engineers to implement new utilities and facility modifications, ensuring seamless integration into manufacturing operations. Experience leading engineering teams through large-scale capital projects.
- Develop and optimize preventive maintenance programs for process, utility, QC, and TRD equipment to minimize downtime and extend asset life.
- Execute asset lifecycle management plans aligned with global Novartis standards, covering design, operation, and retirement phases.
- Drive a data-driven reliability program to maintain validated state of assets and minimize downtime across critical systems.
- Provide clear leadership, coaching, and mentoring for engineers supporting 24/7 operations, fostering a culture of accountability and excellence.
- Own and maintain master data for all site process, utility, QC, and TRD equipment, ensuring accuracy and regulatory compliance.
- Analyze performance trends and implement continuous improvement initiatives to enhance system reliability and support recapitalization planning for critical assets.
- Support site capital projects by creating equipment specifications and standard documentation, including User Requirements (URS), Functional Specification (FS), and Detail Design Specifications (DDS), ensuring compliance and functionality.
- Collaborate with operations and manufacturing sciences to evaluate new product introductions and conduct facility fit assessments for strategic alignment.
Qualifications
- Required: Bachelor’s degree in Engineering or a related technical discipline, with a strong foundation in process and equipment design principles.
- Required: Minimum of 9 years in biotechnology or pharmaceutical operations, with hands-on expertise in process engineering, equipment qualification, and maintenance strategies.
- Required: Proven ability to manage the full lifecycle of production equipment—from design and installation to reliable operation and retirement—while ensuring compliance with global standards.
- Required: Demonstrated success working with diverse teams including Quality Engineering (QE), Quality Assurance (QA), Validation, and Operations to deliver complex projects in a fast-paced environment.
- Required: In-depth understanding of health, safety, and environmental regulations, as well as FDA and global cGMP requirements, ensuring adherence to stringent compliance standards.
- Required: Strong capability to analyze performance data, identify trends, and implement solutions that enhance reliability and efficiency.
- Required: Skilled in MS Office applications, Building Management Systems, and Computerized Maintenance Management Systems (CMMS), with the ability to leverage technology for operational excellence.
- Required: Exceptional interpersonal skills and the ability to lead, mentor, and influence teams while communicating effectively across all organizational levels.
- Preferred: Familiarity with advanced reliability tools and predictive maintenance technologies.
Skills
- MS Office applications, Building Management Systems, and Computerized Maintenance Management Systems (CMMS)
- Data-driven reliability analysis
- Leadership, mentoring, and cross-functional collaboration
Education
- Bachelor’s degree in Engineering or a related technical discipline