Senior Engineer, Automation - Packaging/Serialization

About the role

Novartis is looking for a Senior Engineer, Automation - Packaging/Serialization to provide technical leadership for the automation systems that support packaging operations, serialization processes and product traceability in a GMP-regulated manufacturing facility. The role is based onsite in Durham, NC, and Novartis does not offer relocation support.

Key responsibilities

• Lead automation support for packaging and serialization systems across manufacturing operations.
• Serve as the technical subject matter expert for DCS, BMS, MES and associated control systems.
• Drive automation projects from concept through implementation and operational handoff, overseeing integration of packaging equipment and serialization technologies into site automation platforms.
• Develop URS, FS and design specifications for compliant system delivery, and collaborate with cross-functional teams on priorities and timelines.
• Support new product launches and packaging implementation within GMP manufacturing, investigate automation-related non-conformances and implement corrective actions.
• Execute change controls, system upgrades and continuous improvement initiatives, and provide technical support including on-call rotations.

Required profile

• Bachelor's degree in Engineering, Computer Science or a related technical discipline.
• 8+ years of automation experience in GMP pharmaceutical or biopharmaceutical manufacturing.
• Proven expertise with PLC, SCADA, HMI and manufacturing automation systems.
• Strong knowledge of validation practices, GMP, FDA requirements and 21 CFR Part 11.
• Experience applying ISA-88 principles and developing automation standards in regulated environments.
• Demonstrated project leadership, including managing contractors and external partners.

Required skills

• Hands-on support of DCS platforms, preferably Emerson DeltaV.
• PLC, SCADA, HMI and manufacturing automation systems.
• Validation practices, GMP, FDA requirements and 21 CFR Part 11.
• ISA-88 principles and automation standards development.

What we offer

• Expected salary range of $108,500 to $201,500 per year, depending on skills and experience.
• Performance-based cash incentive and possible eligibility for annual equity awards.
• Health, life and disability benefits, 401(k) with company contribution and match, and a time-off package including vacation, personal days and holidays.