Senior Upstream Automation Engineer - Media GMP

Novartis; Durham (NC); On-site; USD 109,000 - 202,000; Full time

Job summary

Novartis in Durham, NC seeks a Sr. Automation Engineer for Upstream/Media to lead automation support for upstream manufacturing and media processes in a GMP environment.

You will act as the technical SME for DCS, MES, BMS, and related systems, directing projects from concept through implementation and handoff. You will collaborate with cross-functional teams to align priorities, ensure design and validation compliance, and support new product introductions.

Qualifications

• Bachelor's degree in Engineering, Computer Science, or related technical field.
• 8+ years of automation experience in GMP pharmaceutical or biopharmaceutical manufacturing.
• Hands-on experience with DCS platforms, preferably Emerson DeltaV.
• Proven PLC, SCADA, HMI and manufacturing automation systems expertise.
• Strong knowledge of validation practices, GMP regulations, FDA requirements, and 21 CFR Part 11.
• Experience applying ISA-88 principles and developing automation standards in regulated environments.

Responsibilities

• Lead automation support for upstream manufacturing and media process control systems.
• 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 upstream process implementation within GMP manufacturing.
• Investigate automation-related non-conformances and implement corrective actions.
• Execute change controls, system upgrades, and continuous improvement initiatives.
• Provide technical support for manufacturing operations, including on-call rotations.

Skills

Project leadership

Cross-functional teamwork

Troubleshooting

Technical writing

Education

Bachelor's degree in Engineering/CS/related

Tools

Emerson DeltaV

PLC/SCADA/HMI

Validation practices

ISA-88

Job description

Novartis in Durham, NC seeks a Sr. Automation Engineer for Upstream/Media to lead automation support for upstream manufacturing and media processes in a GMP environment.

You will act as the technical SME for DCS, MES, BMS, and related systems, directing projects from concept through implementation and handoff. You will collaborate with cross-functional teams to align priorities, ensure design and validation compliance, and support new product introductions.