Lead Automation Engineer, Downstream/Buffer (GMP)

Novartis

Durham (NC)

On-site

USD 109,000 - 202,000

Full time

5 days ago

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Benefits offered by this job

Health, life and disability benefits

401(k) with company match

Generous time off

Job summary

Novartis in Durham, NC is seeking a Sr. Automation Engineer for Downstream/Buffer. You will lead automation system design, drive project execution, and ensure compliant delivery across GMP manufacturing environments.

This onsite role requires DCS/DeltaV expertise, strong troubleshooting, and collaboration with cross‑functional teams to enable reliable operations. The role emphasizes lifecycle support, validation practices, and implementation of upgrades while supporting new product introductions

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 system design, configuration, maintenance, and lifecycle support 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 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 project objectives.
Support new product introductions and ensure successful transition into 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.