Senior Automation Engineer - Downstream/Buffer (GMP)

Novartis Group Companies; Durham (NC); Presencial; USD 109.000 - 202.000; Jornada completa

Descripción de la vacante

Novartis Group of Companies in Durham, NC is seeking a Sr. Automation Engineer - Downstream/Buffer to lead automation strategy and support compliant manufacturing operations.

This onsite role requires expertise across DCS, PLC, SCADA, and HMI systems, with focus on Emerson DeltaV and validated processes. You will drive projects from concept through implementation, collaborate with cross-functional teams, and ensure smooth transitions to GMP manufacturing.

Formación

• Bachelor's degree in Engineering, Computer Science, or related technical discipline.
• 8+ years of automation experience within GMP pharmaceutical or biopharmaceutical manufacturing environments.
• Hands-on experience supporting DCS platforms, preferably Emerson DeltaV.
• Proven expertise with PLC, SCADA, HMI, and manufacturing automation systems.
• Strong knowledge of validation practices, GMP regulations, FDA requirements, and 21 CFR Part 11.
• Experience applying ISA-88 principles and developing automation standards within regulated environments.
• Demonstrated project leadership experience, including management of contractors and external partners.
• Strong troubleshooting, communication, and technical writing skills with the ability to solve complex challenges.

Responsabilidades

• Lead automation system design, configuration, maintenance, and lifecycle support across manufacturing operations.
• Serve as the technical SME for DCS, BMS, MES, and associated control systems.
• Drive automation project execution from concept through implementation and operational handoff.
• Oversee integration of third-party equipment into site automation and manufacturing platforms.
• Develop URS, FS, and design specifications to support compliant system delivery.
• Collaborate with cross-functional teams to establish priorities, timelines, and project objectives.
• Support new product introductions and ensure successful transition into GMP manufacturing.
• Investigate automation-related non-conformances and implement effective corrective actions.
• Execute change controls, system upgrades, and continuous improvement initiatives.
• Provide technical support for manufacturing operations, including participation in on-call rotations.

Conocimientos

DCS systems

PLC/SCADA/HMI

ISA-88

GMP compliance

Project leadership

Technical writing

Communication

FDA 21 CFR Part 11

Educación

Bachelor's degree in Engineering/CS

Herramientas

Emerson DeltaV

PLC

SCADA/HMI

Descripción del empleo

Novartis Group of Companies in Durham, NC is seeking a Sr. Automation Engineer - Downstream/Buffer to lead automation strategy and support compliant manufacturing operations.

This onsite role requires expertise across DCS, PLC, SCADA, and HMI systems, with focus on Emerson DeltaV and validated processes. You will drive projects from concept through implementation, collaborate with cross-functional teams, and ensure smooth transitions to GMP manufacturing.