Senior Automation Engineer: GMP Downstream/Buffer (Onsite)

Novartis; North Carolina; On-site; USD 109,000 - 202,000; Full time

Job summary

Novartis is seeking a Sr. Automation Engineer - Downstream/Buffer to lead automation strategy and lifecycle support across GMP operations in Durham, NC.

You will design, configure, and troubleshoot DCS/DeltaV-based systems and partner with cross-functional teams to enable compliant, high-performance manufacturing. You will drive projects from concept through implementation, oversee third‑party integrations, and develop URS/FS to support regulated delivery of life-saving medicines.

Qualifications

• Bachelor's degree in Engineering, Computer Science, or a related technical discipline.
• 8+ years of automation experience in 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.

Responsibilities

• 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.

Skills

Automation leadership

GMP manufacturing

Technical writing

Troubleshooting

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

Emerson DeltaV

PLC/SCADA/HMI

ISA-88

Job description

Novartis is seeking a Sr. Automation Engineer - Downstream/Buffer to lead automation strategy and lifecycle support across GMP operations in Durham, NC.

You will design, configure, and troubleshoot DCS/DeltaV-based systems and partner with cross-functional teams to enable compliant, high-performance manufacturing. You will drive projects from concept through implementation, oversee third‑party integrations, and develop URS/FS to support regulated delivery of life-saving medicines.