DeltaV Automation Lead for GMP Manufacturing

Novartis; Durham (CA); Sur place; USD 109 000 - 202 000; Plein temps

Résumé du poste

Novartis in Durham, NC seeks an experienced Sr. Automation Engineer to serve as a DeltaV SME, leading automation initiatives in GMP manufacturing and driving system reliability.

You will design, configure, troubleshoot, and optimize DeltaV control strategies, supporting the full lifecycle from implementation to retirement, while partnering with Manufacturing, Engineering, Quality, Validation, and IT teams to deliver compliant solutions.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Automation, or a related technical field with 8+ years of GMP pharmaceutical or biopharmaceutical manufacturing operations experience.
• Strong hands-on experience programming, troubleshooting, and maintaining DeltaV DCS automation systems.
• Experience with SCADA, HMI, PLC, BMS in regulated environment.
• Knowledge of GMP, FDA, and 21 CFR Part 11 requirements.
• Experience with automation system validation, qualification, and lifecycle management in GMP operations.
• Proven ability to lead automation projects and change controls.
• Experience developing automation documentation and test protocols.
• Strong communication and collaboration across Engineering, Manufacturing, Quality, Validation, and IT teams.

Responsabilités

• Serve as a DeltaV SME, providing technical expertise for automation systems supporting GMP manufacturing operations.
• Design, configure, troubleshoot, and optimize DeltaV control strategies and system performance.
• Support the full automation system lifecycle, including implementation, upgrades, maintenance, and retirement.
• Lead automation projects from concept through commissioning, qualification, and operational handover.
• Partner with Manufacturing, Engineering, Quality, Validation, and IT teams to deliver automation solutions.
• Drive continuous improvement to enhance system reliability, efficiency, and product quality.
• Investigate automation deviations, implement corrective actions, and support CAPA activities.
• Develop and maintain automation documentation, including specifications, test protocols, and system drawings.
• Ensure automation systems remain compliant with GMP, FDA, and data integrity requirements.
• Provide technical mentorship and SME for DeltaV and site automation technologies.

Connaissances

DeltaV DCS

SCADA

HMI

PLC

GMP experience

21 CFR Part 11

Lifecycle management

Validation

Project leadership

Formation

Bachelor’s degree in Engineering, Computer Science, Automation, or a related technical field

Outils

DeltaV

Description du poste

Novartis in Durham, NC seeks an experienced Sr. Automation Engineer to serve as a DeltaV SME, leading automation initiatives in GMP manufacturing and driving system reliability.

You will design, configure, troubleshoot, and optimize DeltaV control strategies, supporting the full lifecycle from implementation to retirement, while partnering with Manufacturing, Engineering, Quality, Validation, and IT teams to deliver compliant solutions.