Senior Automation Engineer – GMP Pharma Systems

Healthcare Businesswomen’s Association; Durham (NC); On-site; USD 99,000 - 183,000; Full time

Job summary

Novartis is seeking an Automation Engineer III focused on Compounding, CIP, SIP, and Utility Distribution systems in Durham, NC. The role supports design, troubleshooting, and lifecycle management across Manufacturing and Quality to ensure GMP compliance and reliable automation.

Qualifications include a Bachelor's degree and 5+ years GMP experience or 9 years equivalent. DeltaV and OSI PI experience are preferred.

Qualifications

• Bachelor's degree in Engineering, Computer Science, or related field.
• 5+ years pharma GMP manufacturing or 9 years equivalent industry.
• Hands-on programming, troubleshooting, and maintenance of DCS platforms (DeltaV).
• Experience supporting compounding, CIP, SIP, utility, PLC, and SCADA/HMI systems.
• Knowledge of automation validation, change controls, and FDA 21 CFR Part 11.
• Experience with OSI PI data historian.

Responsibilities

• Maintain, troubleshoot, and optimize compounding, CIP, SIP, utility distribution, and manufacturing automation systems.
• Support design, configuration, installation, and lifecycle management of automation hardware and software.
• Support automation and control strategies for compounding, CIP, SIP, and utility distribution systems.
• Lead automation activities for capital projects, upgrades, and system enhancements.
• Develop URS, FS, DDS, HDS, and SDS documentation for automation solutions.
• Execute and support change controls, validation activities, and regulatory compliance initiatives.
• Partner with Manufacturing and Quality teams to resolve complex production issues.
• Support GMP manufacturing operations through on-call and operational support activities.
• Drive continuous improvement projects that enhance reliability, compliance, and operational efficiency.
• Maintain automation procedures, SOPs, and system records in alignment with FDA and GMP requirements.

Skills

DCS programming

SCADA/HMI

Automation validation

OSI PI

Instrumentation

Communication skills

Education

Bachelor's degree in Engineering/CS or related

Tools

DeltaV

DCS platforms

PLC/SCADA

OSi PI

Job description

Novartis is seeking an Automation Engineer III focused on Compounding, CIP, SIP, and Utility Distribution systems in Durham, NC. The role supports design, troubleshooting, and lifecycle management across Manufacturing and Quality to ensure GMP compliance and reliable automation.

Qualifications include a Bachelor's degree and 5+ years GMP experience or 9 years equivalent. DeltaV and OSI PI experience are preferred.