Process Engineer III

Socket.dev; Durham (CA); On-site; USD 110,000 - 183,000; Full time

Job summary

Novartis in Durham, NC seeks a Process Engineer III to support startup and ongoing operations of a new large molecule manufacturing facility. You will work across manufacturing systems, equipment lifecycle management, and process optimization in GMP biologics environments.

Responsibilities include designing, installing, qualifying, and starting facilities; supporting upstream/downstream equipment; maintaining validated state; leading deviations and CAPAs; mentoring engineers; and collaborating

Qualifications

• Excellent technical writing, communication, and cross-functional collaboration skills.
• Bachelor's degree in Chemical, Mechanical, Electrical, or related Engineering discipline.

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.

Skills

Technical writing

Communication

Cross-functional collaboration

Education

Bachelor's degree in Chemical, Mechanical, Electrical, or related Engineering discipline

Job description

Band

Level 3

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.

Job Description

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.

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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, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

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 in order to perform the essential functions of a position, please send an e-mail to [e-mail] call [phone] 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, Cost Management, Operational Excellence, Quality Compliance