Senior Automation Engineer, Packaging & Serialization (GMP)

Novartis; North Carolina; On-site; USD 109,000 - 202,000; Full time

Job summary

Novartis in Durham, NC seeks a Senior Engineer, Automation - Packaging/Serialization to lead automation for packaging and serialization across manufacturing operations. You will act as the SME for DCS, BMS, MES, and related control systems, guiding projects from concept to handoff.

You will drive standardization, validation, and equipment integration within GMP manufacturing, collaborating with cross-functional teams, and supporting on-call operations.

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 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.

Skills

Automation systems

GMP manufacturing

ISA-88

Project leadership

Validation practices

FDA requirements

21 CFR Part 11

Troubleshooting

Technical writing

Communication

Education

Bachelor's degree in Engineering, Computer Science, or related technical discipline

Tools

Emerson DeltaV

Job description

Novartis in Durham, NC seeks a Senior Engineer, Automation - Packaging/Serialization to lead automation for packaging and serialization across manufacturing operations. You will act as the SME for DCS, BMS, MES, and related control systems, guiding projects from concept to handoff.

You will drive standardization, validation, and equipment integration within GMP manufacturing, collaborating with cross-functional teams, and supporting on-call operations.