Description

Job Description Summary

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.

Job Description

#LI-Onsite

Location: Durham, NC

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

Key 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

Essential 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

Desirable Requirements

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

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.

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 us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$98,700.00 - $183,300.00

Skills Desired

Business Continuity, Change Control, Cost Management, Data Analytics and Digital, Engineering Technical Expertise, GDP Knowledge, gmp knowledge, HSE Knowledge, Knowledge Of Relevant Tools And Systems , Manufacturing Process (Production), Operational Excellence, Quality Compliance, Resilience and Risk Management, Total Productive Maintenance

Process Engineer III

Description

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