Senior Automation Engineer, Packaging & Serialization

Healthcare Businesswomen’s Association; Durham (NC); On-site; USD 109,000 - 202,000; Full time

Benefits offered by this job

Health, life and disability benefits

401(k) with company match

Vacation and leave

Job summary

Novartis seeks a Senior Engineer, Automation - Packaging/Serialization, to lead automation for packaging, serialization, and product traceability in a GMP manufacturing setting. You will act as a technical SME for DCS/BMS/MES and drive projects from concept through handoff, ensuring compliant, efficient operations.

You will collaborate across functions to prioritize work, support new product launches, and manage contractors, while upholding 21 CFR Part 11 and ISA-88 standards.

Qualifications

• Bachelor's degree in Engineering, Computer Science, or a related technical discipline.
• 8+ years of automation experience within GMP pharma/biopharma manufacturing.
• Hands-on experience with 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 automation standards in regulated environments.
• Demonstrated project leadership, including management of contractors and external partners.
• Strong troubleshooting, communication, and technical writing skills.

Responsibilities

• Lead automation support for packaging and serialization systems across manufacturing operations.
• Serve as the technical SME for DCS, BMS, MES and related control systems.
• Drive automation project execution from concept through implementation and 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 set priorities, timelines, and objectives.
• Support new product launches and packaging implementation in GMP manufacturing.
• Investigate automation-related non-conformances and implement corrective actions.
• Execute change controls, system upgrades, and continuous improvement initiatives.
• Provide technical support for manufacturing operations, including on-call rotations.

Skills

DCS DeltaV

PLC/SCADA

HMI systems

Validation GMP

Project leadership

Technical writing

Troubleshooting

Education

Bachelor's degree in Engineering/CS

Tools

Emerson DeltaV

ISA-88 standards

Job description

Novartis seeks a Senior Engineer, Automation - Packaging/Serialization, to lead automation for packaging, serialization, and product traceability in a GMP manufacturing setting. You will act as a technical SME for DCS/BMS/MES and drive projects from concept through handoff, ensuring compliant, efficient operations.

You will collaborate across functions to prioritize work, support new product launches, and manage contractors, while upholding 21 CFR Part 11 and ISA-88 standards.