Process Engineer III

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.#

LI-OnsiteLocation:

Durham, NCRelocation Support:

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

Key ResponsibilitiesLead start‑up readiness, qualification, and lifecycle management for large‑molecule manufacturing equipment and supporting utility systemsOwn equipment change control, ensuring validated state and regulatory compliance throughout design, installation, and operational phasesProvide technical leadership on capital projects, partnering with project teams to define scope, risks, and robust engineering solutionsServe as engineering subject matter expert during deviations, investigations, and root cause analyses for complex equipment and process issuesDevelop and execute equipment reliability and maintenance strategies aligned with GMP requirements and operational needsAuthor and review equipment specifications, user requirements, functional specifications, and design documentationSupport regulatory inspections and internal audits, representing engineering and responding to observations as neededCollaborate with manufacturing, operations, and manufacturing sciences on new equipment introductions and facility fit assessmentsEvaluate and implement new technologies and equipment platforms to enhance manufacturing capability and future readinessMentor junior engineers and help establish engineering standards as the process engineering team continues to growEssential RequirementsBachelor'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 systemsProven experience supporting capital projects, including equipment design, installation, qualification, and start‑up activitiesIn‑depth knowledge of FDA regulations and Good Manufacturing Practice systems within highly regulated manufacturing facilitiesStrong technical writing skills with experience authoring equipment specifications, protocols, and validation documentationAbility to prepare contingency plans and logically work through complex technical issues in high‑pressure manufacturing and project environmentsDemonstrated ability to build and maintain relationships with senior internal and external stakeholders within your area of expertiseDesirable RequirementsExperience supporting manufacturing or facility start‑up activities within large‑molecule or biologics environmentsExposure to large‑scale capital projects, including participation in high‑value or multi‑phase equipment implementations

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $98,700 and $183,300/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.