Automation Engineer III - Compounding, CIP, SIP, Utility Distribution

About the role

Novartis is looking for an Automation Engineer III in Durham, NC, an onsite role supporting the automation of compounding, CIP, SIP and utility distribution systems in pharmaceutical manufacturing. You will work across Engineering, Manufacturing and Quality to keep critical automation platforms running reliably and in line with GMP compliance.

Key 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.
• 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 and support GMP operations through on-call and operational support.
• Drive continuous improvement projects and maintain procedures, SOPs and records in line with FDA and GMP requirements.

Required profile

• Bachelor's degree in Engineering, Computer Science or a related technical field.
• Minimum 5 years of experience in pharmaceutical or biopharmaceutical GMP manufacturing, or 9 years of equivalent industry experience.
• Hands-on experience programming, troubleshooting and maintaining DCS platforms, preferably DeltaV.
• Experience with compounding, CIP, SIP, utility, PLC and SCADA/HMI systems in GMP manufacturing.
• Knowledge of automation validation, change controls and FDA 21 CFR Part 11.
• Strong understanding of process instrumentation, utility systems, control system architecture and industrial communication protocols.

Required skills

• DCS platforms, preferably DeltaV
• PLC and SCADA/HMI systems
• Data historian technologies, preferably OSI PI
• Automation validation and FDA 21 CFR Part 11

What we offer

• Expected salary range of $98,700 to $183,300 per year, depending on skills and experience.
• Performance-based cash incentive and possible annual equity awards.
• Health, life and disability benefits, 401(k) with company contribution and match.
• Vacation, personal days, holidays and other leaves.