Sr. Mgr. Process / Project Engineering

Novartis • Durham, CA

1d • Onsite

About The Position

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.

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.

Nice To Haves

• Familiarity with advanced reliability tools and predictive maintenance technologies.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager