Senior Automation Engineer – Packaging & Serialization Lead

NCBiotech

Durham (NC)

On-site

USD 109,000 - 202,000

Full time

14 days+

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Benefits offered by this job

Onsite role

Job summary

Novartis in Durham, NC is seeking a Senior Engineer, Automation - Packaging/Serialization to provide technical leadership for automation systems that support packaging operations, serialization processes, and product traceability in a GMP environment.

You will drive project execution from concept through implementation, integrate packaging equipment and serialization technologies into site automation platforms, and develop URS, FS, and design specs while collaborating with cross-functional

Qualifications

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