Senior Process Engineer, Biologics Manufacturing

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

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