Sr. Automation Engineer Drug Product

Role: Senior Automation Engineer leading automation design and technical expertise at a Novartis Aseptic Drug Product facility. Responsibilities include ensuring automation of new equipment meets standards, overseeing system integration with plant systems, developing automation software/hardware, and managing project scopes, timelines, and contractors. The role involves leading lifecycle documentation, GMP compliance, supporting product transfers, driving continuous improvement, and participating in audits as an automation SME. Requirements: B.S. in Engineering, Computer Science, or related field; 8+ years in pharmaceutical GMP manufacturing (or 12+ years in lieu); experience programming/maintaining DCS, BMS, PLC, SCADA, and industrial protocols; familiarity with FDA regulations, especially 21 CFR part 11; strong project management skills and technical writing ability. Preferred skills include expertise in S88 control standards, instrumentation, troubleshooting, and qualification testing. High-Value: biologics or aseptic manufacturing, GMP environment, automation in pharmaceutical production, validation/compliance focus, field wiring, and panel design. Collaboration includes working closely with manufacturing, quality, and C&Q teams. Location: On-site Durham, NC, with up to 10% travel.