Senior Automation Engineer – Pharma CIP/SIP & Utilities

Novartis; Durham (NC); 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 maintain and optimize GMP manufacturing automation. You will troubleshoot, implement control strategies, and drive improvements across Engineering, Manufacturing and Quality teams.

Required: Bachelor's in Engineering or related field and 5+ years in pharma GMP; hands-on DeltaV DCS experience; knowledge of FDA 21 CFR Part 11; on-site role in Durham.

Qualifications

• Bachelor's degree in Engineering, Computer Science, or a related technical field.
• Minimum 5 years of pharma GMP manufacturing experience or 9 years equivalent 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 cross-functional 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

DCS platforms (DeltaV)

GMP manufacturing systems

Automation validation & 21 CFR Part 11

OSI PI historian

Process instrumentation & control

Cross-functional collaboration

Education

Bachelor's degree in Engineering/related field

Tools

DeltaV

OSI PI

PLC/SCADA/HMI tools

Job description

Novartis in Durham, NC is seeking an Automation Engineer III focused on compounding, CIP, SIP, and utility distribution to maintain and optimize GMP manufacturing automation. You will troubleshoot, implement control strategies, and drive improvements across Engineering, Manufacturing and Quality teams.

Required: Bachelor's in Engineering or related field and 5+ years in pharma GMP; hands-on DeltaV DCS experience; knowledge of FDA 21 CFR Part 11; on-site role in Durham.