Automation Architect — Gene Therapies

Novartis; Durham (NC); On-site; USD 124,000 - 186,000; Full time

Benefits offered by this job

Benefits package

Relocation assistance

Onsite work

Job summary

Novartis is seeking a Senior Automation Engineer for Gene Therapies to lead automation design, develop system specifications, and drive continuous improvement at the Durham site. You will manage DCS/BMS/MES and 3rd party integrations, while ensuring GMP/21 CFR 11 compliance and robust change control processes.

The role requires extensive experience with DeltaV, Rockwell, and OSI PI, along with strong project management and technical writing capabilities.

Qualifications

• Bachelor's degree in Engineering, Computer Science or related field.
• 8–12 years of GMP/pharma manufacturing experience (or 12 years) in pharma GMP manufacturing.
• Experience with DeltaV/PLC/OEM systems and data historians.
• Strong communication and technical writing skills.

Responsibilities

• Design, configure, install, and maintain automation software and hardware.
• Oversee automation aspects of projects and integrate third-party equipment.
• Develop URS, FS, and DDS/HDS/SDS documentation.
• Lead validation and change control activities for automation systems.
• Support 24x7 site operations and on-call responsibilities.

Skills

Communication

Project management

Technical writing

Problem solving

Education

B.S. in Engineering/CS

Tools

DeltaV

PLC

Lab systems

Statistica Software

Rockwell FactoryTalk View SE

OSi PI

Job description

Novartis is seeking a Senior Automation Engineer for Gene Therapies to lead automation design, develop system specifications, and drive continuous improvement at the Durham site. You will manage DCS/BMS/MES and 3rd party integrations, while ensuring GMP/21 CFR 11 compliance and robust change control processes.

The role requires extensive experience with DeltaV, Rockwell, and OSI PI, along with strong project management and technical writing capabilities.