Senior Automation Engineer, GMP Drug Product (On-Site)

Novartis; Durham (NC); On-site; USD 109,000 - 202,000; Full time

Job summary

Novartis in Durham, NC is seeking a Senior Automation Engineer to lead the automation design team and act as a technical SME for our aseptic drug product facility. This on‑site role focuses on GMP compliance, process automation integration, and continuous improvement within a fast‑paced manufacturing environment.

Responsibilities include designing and maintaining automation systems (DCS/BMS/PLC/SCADA), preparing project scopes, and partnering with Quality for audits.

Qualifications

• BS degree in Engineering, Computer Science, or related field.
• 8 years work experience in pharma GMP operations (12 years acceptable).
• Excellent oral and written communication, including technical writing.
• Experience in automation systems: DCS, BMS, PLC, SCADA and historian.
• Experience with qualification testing and S88 in automated environments.
• FDA 21 CFR part 11 and GMP systems knowledge.
• Strong project management and long‑term planning abilities.
• Ability to work under pressure and travel up to 10%.

Responsibilities

• Lead automation design team and serve as SME for the facility.
• Oversee automation aspects of projects and integration with plant systems.
• Design, configure, install and maintain automation software and hardware.
• Prepare scopes of work, lead small teams and manage contractors.
• Collaborate with business partners on priorities and timelines.
• Develop lifecycle documentation such as URS, FS, DDS/SDS.
• Maintain GMP procedures and participate in regulatory audits.
• Support product implementation from process development to GMP manufacturing.
• Drive operational excellence and continuous improvement.
• Provide technical support for manufacturing issues and on‑call coverage.
• Assist investigations of non-conformances related to automation.

Skills

Automation leadership

Project management

Technical writing

Troubleshooting

Education

BS in Engineering or related field

Tools

DCS

BMS

PLC

SCADA

Historian

Industrial protocols

Job description

Novartis in Durham, NC is seeking a Senior Automation Engineer to lead the automation design team and act as a technical SME for our aseptic drug product facility. This on‑site role focuses on GMP compliance, process automation integration, and continuous improvement within a fast‑paced manufacturing environment.

Responsibilities include designing and maintaining automation systems (DCS/BMS/PLC/SCADA), preparing project scopes, and partnering with Quality for audits.