Senior Upstream Automation Engineer – GMP Media

Healthcare Businesswomen’s Association; Durham (NC); On-site; USD 109,000 - 202,000; Full time

Job summary

Novartis is seeking a Sr. Automation Engineer - Upstream/Media to lead automation support for upstream manufacturing and media processes in a GMP setting. You will act as a technical SME for DCS, BMS, MES and related systems, guiding project execution from concept to handoff.

You will collaborate with cross‑functional teams, drive continuous improvement, and support new product introductions while ensuring compliance with validation practices and regulatory requirements.

Qualifications

• Bachelor's degree in Engineering, Computer Science, or related technical field.
• 8+ years automation experience in GMP pharma or biopharma manufacturing.
• Hands-on with DCS platforms, preferably Emerson DeltaV.
• Experience with PLC, SCADA, HMI and manufacturing automation.
• Knowledge of validation practices, GMP, FDA, and 21 CFR Part 11.
• ISA-88 principles and automation standards in regulated environments.
• Proven project leadership including management of contractors and external partners.
• Strong troubleshooting, communication, and technical writing skills.

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 specs to support compliant system delivery.
• Collaborate with cross‑functional teams to set priorities and timelines.
• Support new product introductions and upstream process implementation in GMP manufacturing.
• Investigate automation non-conformances and implement CAPA.
• Execute change controls and system upgrades; drive continuous improvement.
• Provide technical support for manufacturing operations and on-call coverage.

Skills

DCS platforms

PLC/SCADA/HMI

Validation & GMP

Project leadership

Troubleshooting

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Engineering/CS

Tools

Emerson DeltaV

PLC

SCADA

HMI

ISA-88

Job description

Novartis is seeking a Sr. Automation Engineer - Upstream/Media to lead automation support for upstream manufacturing and media processes in a GMP setting. You will act as a technical SME for DCS, BMS, MES and related systems, guiding project execution from concept to handoff.

You will collaborate with cross‑functional teams, drive continuous improvement, and support new product introductions while ensuring compliance with validation practices and regulatory requirements.