Sr. Mgr. Process / Project Engineering

Job Description Summary
#LI-Onsite

This role is based in Durham, NC. Novartis is unable to offer relocation support: please only apply if accessible.

Imagine leading a team that ensures the heartbeat of our manufacturing operations never skips a beat. As Senior Manager, Process / Project Engineering, you'll drive reliability and innovation for critical equipment, shaping the future of drug product manufacturing. Your leadership will empower teams, optimize processes, and make a tangible impact on patient access to life-changing medicines.

Job Description

Company will not sponsor visas for this position.

Key Responsibilities:

• Lead a team of engineers to implement new drug product equipment 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.

Essential Requirements:

• Bachelor's degree in Engineering or a related technical discipline, with a strong foundation in process and equipment design principles.
• Minimum of 9 years in biotechnology or pharmaceutical operations, with hands-on expertise in process engineering, equipment qualification, and maintenance strategies.
• 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.
• 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.
• In-depth understanding of health, safety, and environmental regulations, as well as FDA and global cGMP requirements, ensuring adherence to stringent compliance standards.
• Strong capability to analyze performance data, identify trends, and implement solutions that enhance reliability and efficiency.
• Skilled in MS Office applications, Building Management Systems, and Computerized Maintenance Management Systems (CMMS), with the ability to leverage technology for operational excellence.
• Exceptional interpersonal skills and the ability to lead, mentor, and influence teams while communicating effectively across all organizational levels.

Desirable Requirements:

• Familiarity with advanced reliability tools and predictive maintenance technologies.

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $114,100 and $211,900 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range
$114,100.00 - $211,900.00

Skills Desired
Api (Application Programming Interface), Api (Application Programming Interface), Automation, Back-End Development, Business Continuity, Change Control, Chemistry, Design Development, Electronic Components, General Hse Knowledge , Including Gdp, Java (Programming Language), Knowledge Of Capa, Knowledge Of Gmp, Kubernetes, Managing Performance Improvement, Manufacturing Production, Mathematical Optimization, Project Commissioning, Project Engineering, Project Execution, Reactjs, Risk Management, Root Cause Analysis (RCA), Scheduler {+ 2 more}