Lead Automation Engineer, Packaging & Serialization

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

Job summary

Novartis Group of Companies in Durham, NC seeks a Senior Engineer, Automation - Packaging/Serialization to lead automation systems across packaging operations, serialization, and product traceability in a GMP environment.

You will drive automation project execution from concept through implementation, support DCS/DeltaV, PLC/SCADA/HMI, and coordinate with cross-functional teams to deliver compliant, efficient packaging solutions.

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 packaging and serialization systems 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 packaging equipment and serialization technologies into site automation 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 launches and packaging implementation activities within 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

Industrial automation

DeltaV

PLC

SCADA

HMI

Validation

GMP

ISA-88

Project leadership

Technical writing

Education

Bachelor's degree in Engineering or CS

Tools

DCS (DeltaV)

BMS

MES

Job description

Novartis Group of Companies in Durham, NC seeks a Senior Engineer, Automation - Packaging/Serialization to lead automation systems across packaging operations, serialization, and product traceability in a GMP environment.

You will drive automation project execution from concept through implementation, support DCS/DeltaV, PLC/SCADA/HMI, and coordinate with cross-functional teams to deliver compliant, efficient packaging solutions.