Process Engineer III

Overview

Job Description Summary

Location:

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

As a Process Engineer III supporting our Technical Research & Development (TRD) organization, you'll own the engineering and validation lifecycle for critical process manufacturing equipment, facilities, and utilities—shaping qualification strategy, leading change control, and driving investigations that strengthen quality and prevent recurrence. You'll partner closely with Operations and Manufacturing Sciences to translate current and future processes into fit-for-purpose facility and equipment requirements, while mentoring other engineers and helping advance technology and equipment platforms that keep the site ready for what’s next.

• Provide engineering, validation, and maintenance support to process manufacturing equipment, facilities, and utilities, including bioreactors, tangential flow filtration, chromatography, filling equipment, incubators, freezers, biosafety cabinets, benchtop instruments, and facility or utility systems.
• Define, develop, and continuously improve equipment qualification and validation strategies to ensure sustained compliance across the full equipment lifecycle.
• Own and manage change control activities for process equipment, ensuring changes are assessed, implemented, and documented to maintain validated state.
• Lead complex equipment and process deviation investigations, perform root cause analysis, and implement corrective and preventive actions to prevent recurrence.
• Act as a subject matter expert for process equipment, facilities, and utilities during regulatory inspections and internal audits, including preparation and response to observations.
• Design and implement equipment reliability and maintenance strategies that balance compliance, operational effectiveness, and cost efficiency.
• Author and review equipment specifications and engineering documentation, including User Requirements, Functional Specifications, and Detailed Design Specifications.
• Independently lead or provide technical leadership on capital projects, including equipment selection, design review, installation, commissioning, and qualification.
• Collaborate closely with Operations and Manufacturing Sciences to assess equipment capability, facility fit, and readiness for new product introductions.
• Evaluate emerging manufacturing technologies and equipment platforms and contribute to long-term facility and equipment roadmaps aligned with strategic plans.

• B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with 5 years' work experience in pharmaceutical or biopharmaceutical GMP manufacturing operations, or equivalent work experience (9 years) in pharmaceutical or biopharmaceutical GMP manufacturing operations in lieu of a degree.
• Demonstrated experience providing engineering support for complex process equipment, facilities, and utilities within highly regulated manufacturing environments.
• In-depth working knowledge of health authority regulations, current Good Manufacturing Practice (GMP) systems, and validation expectations.
• Proven ability to lead technical investigations, manage change control, and develop corrective and preventive actions in response to deviations.
• Strong technical writing and communication skills, with experience authoring qualification, validation, and engineering documentation.
• Experience leading or contributing to capital projects, including equipment specification, design review, installation, commissioning, and qualification.
• Ability to collaborate effectively across Engineering, Operations, Quality, and Manufacturing Sciences in a fast-paced, matrixed environment.

• Experience supporting Technical Research and Development, clinical, or early-phase manufacturing operations within pharmaceutical or biopharmaceutical environments.
• Demonstrated experience mentoring engineers or leading small cross-functional technical teams across manufacturing or development sites.

The…