Process Engineer III

Job Description Summary

#LI-Onsite

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

As a Process Engineer III, you will provide advanced engineering expertise to ensure robust, compliant, and efficient drug product manufacturing operations. You'll lead equipment lifecycle activities-from design and qualification through validation and maintenance-while driving reliability strategies and implementing cutting-edge technologies. Your role will involve optimizing filling lines, isolators, automated inspection systems, and packaging processes, ensuring seamless integration with facility and utility systems to support global manufacturing standards.

Job Description

Key Responsibilities :

• Primary responsibilities for this role will be with drug product equipment and processes, to include filling lines, isolators, automated visual inspection, device assembly, and packaging.
• Ensures new equipment is appropriately designed / qualified and existing processes run in a compliant manner through equipment life cycle. Help define and optimize equipment qualification strategy.
• Owns and manages changes to process equipment to maintain validated state; may drive global consistency across sites.
• Investigates equipment or process deviations and develops corrective actions; provides expertise for complex investigations.
• Serves as SME during FDA and internal audits; responds to observations and ensures compliance.
• Develops and implements equipment reliability and maintenance strategies that are compliant, effective, and cost-appropriate.
• Provides mentorship to process engineers and leads small teams to optimize systems and processes, including creating User Requirements Specifications (URS), Functional Specifications (FS), and Detailed Design Specifications (DDS).
• Leads or supports capital projects and establishes equipment specifications.
• Evaluates new product introductions and facility fit; advances facility and equipment changes aligned with strategic plans.
• Assesses and introduces new technologies and equipment platforms to enhance manufacturing capabilities.

Essential Requirements :

Desirable Requirements :

Novartis Compensation and Benefit Summary :

The salary for this position is expected to range between $89,600 and $166,400 per 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.

Company will not sponsor visas for this position.

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

$89,600.00 - $166,400.00

Skills Desired

Agile (Programming Methodology), Architectural Engineering, Aws (Amazon Web Services), Business Continuity, Business Networking, Change Control, Computer Science, Construction Management, Cost Management, Flexibility, General Hse Knowledge, HVAC (Heating Ventilation And Air Conditioning), Including Gdp, Installations (Computer Programs), Knowledge Of Capa, Knowledge Of Gmp, Knowledge Of Relevant Tools And Systems , Manufacturing Production, Project Commissioning, Project Engineering, Project Execution, Risk Management, Root Cause Analysis (RCA), Software Development, Total Productive Maintenance