Lead Automation Engineer, Packaging & Serialization

U061 (FCRS = US061) Novartis Services, Inc.

Durham (NC)

On-site

USD 109,000 - 202,000

Full time

4 days ago

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Benefits offered by this job

On-site in Durham

Job summary

Novartis seeks a Senior Engineer, Automation - Packaging/Serialization in Durham, NC, onsite. You will provide technical leadership for automation systems supporting packaging operations, serialization, and product traceability in a GMP manufacturing environment, driving innovation, enhancing performance, and leading critical projects that strengthen compliance and supply chain integrity.

You will oversee automation integration across DCS, BMS, MES, and control systems, develop specifications,

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, and21CFR Part11.
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.