Senior Upstream Automation Engineer - GMP Media

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

Job summary

Novartis Group of Companies seeks a Sr. Automation Engineer - Upstream/Media to lead automation for upstream manufacturing and media operations.

You will be the technical SME for DCS, BMS, MES, and related systems, driving projects from concept through handoff in a GMP setting. With 8+ years in pharmaceutical/biopharma automation, you will develop URS/FS, manage contractors, and ensure compliant system delivery while supporting change controls and continuous improvements.

Qualifications

• Bachelor's degree in Engineering, Computer Science, or a 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.

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 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 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

DCS platforms

PLC

SCADA

HMI

ISA-88

Project leadership

Validation

GMP/FDA knowledge

Technical writing

Education

Bachelor's degree in Engineering or related field

Tools

Emerson DeltaV

Job description

Novartis Group of Companies seeks a Sr. Automation Engineer - Upstream/Media to lead automation for upstream manufacturing and media operations.

You will be the technical SME for DCS, BMS, MES, and related systems, driving projects from concept through handoff in a GMP setting. With 8+ years in pharmaceutical/biopharma automation, you will develop URS/FS, manage contractors, and ensure compliant system delivery while supporting change controls and continuous improvements.