Process Engineer III
Novartis
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.
Job description
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.
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.
- Experience supporting utility systems such as WFI, Clean Steam, and other GMP utilities.
- Experience with facility startup, equipment qualification, commissioning, or technology transfer activities.
Benefits
- Health benefits
- Life insurance
- Disability benefits
- 401(k) with company contribution and match
- Performance-based cash incentive
- Annual equity awards
- Vacation
- Personal days
- Holidays
Company overview
Novartis is a global pharmaceutical company headquartered in Basel, Switzerland, dedicated to reimagining medicine to improve and extend people's lives. As an innovative medicines company, Novartis focuses on developing high-value treatments that address society's greatest disease burdens through technology leadership in research and development. The company operates across five core therapeutic areas: cardiovascular, renal and metabolic diseases; immunology; neuroscience; oncology; and hematology. With a workforce of approximately 75,883 employees worldwide, Novartis reaches nearly 300 million patients across 118 countries. The company leverages advanced technology platforms including targeted protein degradation, cell therapy, gene therapy, radioligand therapy, and xRNA to develop breakthrough treatments. Novartis maintains a strong portfolio of oncology drugs and generics while continuously expanding its pipeline through strategic acquisitions and internal research. The company's commitment extends beyond drug development to ensuring global access to medical innovations through novel access approaches and patient assistance programs.