Process Engineer III

Novartis • Durham, NC

6d • Onsite

About The Position

Help shape the future of biologics manufacturing at Novartis. As a Process Engineer III, you will support the startup and long-term operation of a new large molecule manufacturing facility in Durham, working across manufacturing systems, equipment lifecycle management, and process optimization. We're looking for an engineer with experience in GMP biologics manufacturing who is excited to make an impact in a growing operation, particularly within upstream processing and large-scale stainless steel biologics manufacturing environments.

Requirements

• Bachelor's degree in Chemical, Mechanical, Electrical, or related Engineering discipline.
• Minimum 5 years of experience in pharmaceutical or biopharmaceutical GMP manufacturing operations, or equivalent experience.
• Experience supporting large molecule, biologics, or biotechnology manufacturing environments.
• Experience with upstream processing equipment and manufacturing systems.
• Experience working in stainless steel biopharmaceutical manufacturing facilities.
• Strong knowledge of FDA regulations, GMP requirements, and validated manufacturing systems.
• Excellent technical writing, communication, and cross-functional collaboration skills.
• Demonstrated ability to solve complex technical problems and lead initiatives in a fast-paced manufacturing environment.

Nice To Haves

• Experience supporting utility systems such as WFI, Clean Steam, and other GMP utilities.
• Experience with facility startup, equipment qualification, commissioning, or technology transfer activities.
• Business Continuity
• Cost Management
• Operational Excellence
• Quality Compliance

Responsibilities

• Support the design, installation, qualification, and startup of a new large molecule manufacturing facility.
• Provide engineering support for upstream and downstream process equipment within a large-scale stainless steel biologics facility.
• Maintain process equipment in a validated state through change control and compliance practices.
• Lead investigations of equipment and process deviations and implement effective CAPAs.
• Develop and execute equipment reliability and maintenance strategies.
• Partner with Operations, Quality, Validation, and MS&T to improve manufacturing performance.
• Establish equipment specifications, including URS, FS, and DDS documentation.
• Serve as an SME during FDA inspections and internal audits.
• Support manufacturing systems including bioreactors, filtration, chromatography, and related process equipment.
• Mentor junior engineers and lead cross-functional initiatives that improve engineering processes.

Benefits

• 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
• performance-based cash incentive
• eligibility to be considered for annual equity awards

What This Job Offers

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