Process Engineer III

Novartis • Durham, CA

5d • Onsite

About The Position

This is a high‑impact opportunity for an experienced Process Engineer who thrives in complex, fast‑paced manufacturing environments and enjoys building and stabilizing operations as programs come online. As the first Process Engineer III hired into a growing team, you will play a critical role in start‑up readiness, shaping equipment strategies, supporting capital project execution, and ensuring robust qualification and lifecycle management across bioreactors, tangential flow filtration, chromatography, filling equipment, and supporting facility and utility systems. The work will evolve as new equipment is introduced and manufacturing capabilities expand, requiring flexibility, strong engineering judgment, and comfort navigating change. For engineers who enjoy hands‑on involvement during start‑up phases and want the opportunity to help define standards as a team grows, this role offers both challenge and visibility.

Requirements

• Bachelor's degree in chemical, Electrical or Mechanical Engineering, or related technical field, with 5 years' work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or equivalent work experience (9 years) in pharmaceutical or biopharmaceutical based GMP manufacturing operations.
• Demonstrated hands‑on experience with large‑molecule manufacturing equipment, including bioreactors, filtration, chromatography, or filling systems
• Proven experience supporting capital projects, including equipment design, installation, qualification, and start‑up activities
• In‑depth knowledge of FDA regulations and Good Manufacturing Practice systems within highly regulated manufacturing facilities
• Strong technical writing skills with experience authoring equipment specifications, protocols, and validation documentation
• Ability to prepare contingency plans and logically work through complex technical issues in high‑pressure manufacturing and project environments
• Demonstrated ability to build and maintain relationships with senior internal and external stakeholders within your area of expertise

Nice To Haves

• Experience supporting manufacturing or facility start‑up activities within large‑molecule or biologics environments
• Exposure to large‑scale capital projects, including participation in high‑value or multi‑phase equipment implementations

Responsibilities

• Lead start‑up readiness, qualification, and lifecycle management for large‑molecule manufacturing equipment and supporting utility systems
• Own equipment change control, ensuring validated state and regulatory compliance throughout design, installation, and operational phases
• Provide technical leadership on capital projects, partnering with project teams to define scope, risks, and robust engineering solutions
• Serve as engineering subject matter expert during deviations, investigations, and root cause analyses for complex equipment and process issues
• Develop and execute equipment reliability and maintenance strategies aligned with GMP requirements and operational needs
• Author and review equipment specifications, user requirements, functional specifications, and design documentation
• Support regulatory inspections and internal audits, representing engineering and responding to observations as needed
• Collaborate with manufacturing, operations, and manufacturing sciences on new equipment introductions and facility fit assessments
• Evaluate and implement new technologies and equipment platforms to enhance manufacturing capability and future readiness
• Mentor junior engineers and help establish engineering standards as the process engineering team continues to grow

Benefits

• performance-based cash incentive
• eligibility to be considered for annual equity awards
• health, life and disability benefits
• a 401(k) with company contribution and match
• a variety of other benefits
• generous time off package including vacation, personal days, holidays and other leaves

What This Job Offers

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