Process Engineer III

U473 (FCRS = US473) Novartis Innovative Technologies Inc; North Carolina; On-site; USD 99,000 - 183,000; Full time

Job summary

Novartis is building a new large molecule manufacturing facility in Durham, NC, seeking a Process Engineer III to support startup and ongoing operations with emphasis on upstream processing and stainless steel manufacturing environments. The role requires a Bachelor's degree in engineering, 5+ years in GMP biopharmaceutical manufacturing, and strong collaboration across Quality, Validation, and Operations.

This onsite position involves leading investigations, maintaining validated equipment, and

Qualifications

• Bachelor's degree in Chemical, Mechanical, Electrical, or related Engineering discipline.
• Minimum 5 years of pharmaceutical or biopharmaceutical GMP manufacturing operations.
• Experience with upstream/downstream processing equipment.
• Experience in stainless steel biopharmaceutical facilities.
• Strong knowledge of FDA regulations and validated manufacturing systems.
• Excellent technical writing and cross-functional collaboration skills.
• Demonstrated ability to lead investigations and CAPAs in a fast-paced manufacturing environment.

Responsibilities

• Support the design, installation, qualification, and startup of a new large molecule manufacturing facility.
• Provide engineering support for upstream and downstream process equipment in a large-scale facility.
• Maintain process equipment in a validated state through change control and compliance practices.
• Lead investigations of equipment and process deviations and implement CAPAs.
• Develop and execute equipment reliability and maintenance strategies.
• Partner with Operations, Quality, Validation, and MS&T to improve 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 equipment.
• Mentor junior engineers and lead cross-functional initiatives to improve processes.

Skills

GMP Biologics

Upstream Processing

Process Equipment

Cross-functional Collaboration

Technical Writing

Education

Bachelor's degree in Chemical/Mechanical/Electrical Engineering

Tools

Stainless steel facilities

Job description

Job Description Summary

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.

Location: This position will be located in Durham, NC and will be an onsite role. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Key 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.

Essential 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.

Desirable Requirements

• Experience supporting utility systems such as WFI, Clean Steam, and other GMP utilities.
• Experience with facility startup, equipment qualification, commissioning, or technology transfer activities.

Novartis Compensation and Benefit Summary

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

Skills Desired

• Business Continuity
• Cost Management
• Operational Excellence
• Quality Compliance

Salary Range $98,700.00 - $183,300.00

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 [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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.

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