Senior Automation Engineer — GMP Drug Product Lead

Production / Manufacturing; Durham (NC); On-site; USD 109,000 - 202,000; Full time

Job summary

Novartis is seeking a Senior Automation Engineer to lead the automation design team at the Durham, NC aseptic drug product facility. You will serve as a subject matter expert for automation, coordinating with EHS, QA, and manufacturing to ensure compliant, scalable automation solutions.

You will oversee design, commissioning, validation, and lifecycle documentation, with a focus on S88-aligned control standards, and contribute to continuous improvement initiatives within an on-site, 24x7

Qualifications

• B.S. degree in Engineering, Computer Science, or related technical field.
• 8 years of experience in pharma GMP manufacturing, or 12 years equivalent.
• Excellent oral and written communication, including technical writing.
• Experience programming, troubleshooting, and maintaining DCS/BMS/PLC/SCADA systems.
• Experience in system qualification testing and QA/QC alignment with C&Q.
• Proven experience applying S88 in automated environments and developing control standards.
• Experience with field wiring, panel design, and instrumentation.
• Experience writing and executing complex change controls.
• Strong knowledge of FDA regulations, 21 CFR part 11, and GMP systems.
• Strong project management and long-term planning skills.
• Ability to handle pressure and travel up to 10%.

Responsibilities

• Lead automation design teams and act as SME for the facility.
• Oversee automation aspects of projects and third-party equipment integration.
• Design, configure, install, and maintain automation software and hardware.
• Prepare scopes of work and manage contractors to meet timelines.
• Lead discussions with business partners on priorities and timelines.
• Develop and approve URS, FS, DDS/HDS/SDS lifecycle documents.
• Develop procedures to meet GMP/CFR requirements and internal policies.
• Support product implementation from development to GMP manufacturing.
• Drive operational excellence and continuous improvement.
• Collaborate with Quality to ensure a compliant manufacturing environment.
• Provide technical support for manufacturing issues and on-call rotations.
• Investigate non-conformances related to automation systems.

Skills

Automation expertise

Cross-functional collaboration

Regulatory knowledge

Problem solving

Communication

Project management

Education

B.S. in Engineering/CS

Tools

DCS

BMS

PLC

SCADA

Historian

GMP/Compliance tools

Job description

Novartis is seeking a Senior Automation Engineer to lead the automation design team at the Durham, NC aseptic drug product facility. You will serve as a subject matter expert for automation, coordinating with EHS, QA, and manufacturing to ensure compliant, scalable automation solutions.

You will oversee design, commissioning, validation, and lifecycle documentation, with a focus on S88-aligned control standards, and contribute to continuous improvement initiatives within an on-site, 24x7