Senior Automation Engineer - Downstream/Buffer (Onsite)

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

Job summary

Novartis in Durham, NC seeks a Sr. Automation Engineer - Downstream/Buffer to lead automation strategy across GMP manufacturing. You will design, implement, and support DCS, BMS, MES systems and partner with cross-functional teams to ensure compliant, efficient operations.

You will manage projects from concept to handoff, integrate third-party equipment, write URS/FS, and drive continuous improvement while supporting on-call manufacturing needs.

Qualifications

• Bachelor's degree in Engineering, Computer Science, or a related technical discipline.
• 8+ years of automation experience within GMP pharmaceutical or biopharmaceutical 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 operational 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.

Skills

DCS DeltaV

PLC/SCADA

HMI

Validation GMP

Project leadership

Technical writing

Regulatory compliance

Education

Bachelor's degree

Tools

Emerson DeltaV

SCADA software

GMP validation tools

Job description

Novartis in Durham, NC seeks a Sr. Automation Engineer - Downstream/Buffer to lead automation strategy across GMP manufacturing. You will design, implement, and support DCS, BMS, MES systems and partner with cross-functional teams to ensure compliant, efficient operations.

You will manage projects from concept to handoff, integrate third-party equipment, write URS/FS, and drive continuous improvement while supporting on-call manufacturing needs.