Automation Engineer III: Pharma GMP (CIP/SIP, DeltaV)

Novartis AG; North Carolina; On-site; USD 99,000 - 183,000; Full time

Job summary

Novartis in Durham, NC is seeking an Automation Engineer III focused on compounding, CIP, SIP, and utility distribution to ensure GMP‑compliant, reliable manufacturing. You will troubleshoot, lead automation projects, develop documentation, and collaborate across Engineering, Manufacturing, and Quality.

You will drive continuous improvements, support change controls and validation, and maintain SOPs and system records in alignment with FDA and GMP requirements.

Qualifications

• Bachelor's degree in Engineering, Computer Science, or a related technical field.
• Minimum 5 years of experience in pharmaceutical or biopharmaceutical GMP manufacturing operations, or 9 years of equivalent industry experience.
• Hands‑on experience programming, troubleshooting, and maintaining DCS platforms, preferably DeltaV.
• Experience supporting compounding, CIP, SIP, utility, PLC, and SCADA/HMI systems in GMP manufacturing.
• Knowledge of automation validation, change controls, and FDA 21 CFR Part 11 requirements.
• Experience with data historian technologies, preferably OSI PI.
• Strong understanding of process instrumentation, utility systems, control system architecture, and industrial communication protocols.
• Excellent communication and collaboration skills with the ability to work across technical and business teams.

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

DeltaV DCS

GMP manufacturing

OSI PI

DCS programming

Education

Bachelor's degree in Engineering, Computer Science, or related technical field

Tools

OSI PI

Job description

Novartis in Durham, NC is seeking an Automation Engineer III focused on compounding, CIP, SIP, and utility distribution to ensure GMP‑compliant, reliable manufacturing. You will troubleshoot, lead automation projects, develop documentation, and collaborate across Engineering, Manufacturing, and Quality.

You will drive continuous improvements, support change controls and validation, and maintain SOPs and system records in alignment with FDA and GMP requirements.