Senior Automation Engineer – Pharma GMP, On-Site

Biopharma Careers

North Carolina

On-site

USD 109,000 - 202,000

Full time

5 days ago

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Job summary

Novartis in Durham, NC is seeking a Senior Automation Engineer to lead a design team and serve as the automation SME for a GMP aseptic drug product facility. This on-site role requires coordinating with Quality, Regulatory, and operations to ensure compliant automation solutions.

The engineer will oversee project automation, lifecycle documentation, and 24x7 site support, including on-call duties. The successful candidate will have a BS in Engineering or related field, 8–12 years pharma GMP

Qualifications

B.S. degree in Engineering, Computer Science, or related technical field.
8 years in pharma GMP manufacturing (or 12 years equivalent).
Excellent oral and written communication skills.
Experience programming, troubleshooting, and maintaining DCS/BMS/PLC/SCADA systems.
Experience with S88 and control system standards.

Responsibilities

Lead automation design efforts for new equipment to meet standards and be commissioned.
Oversee automation aspects of projects, including third-party integration with plant systems.
Design, configure, install, and maintain automation software and hardware.
Prepare scopes of work, lead teams, and manage automation contractors.
Lead discussions with stakeholders on priorities and timelines.
Develop and approve URS/FS/DDS/HDS/SDS lifecycle docs.
Support GMP compliance and regulatory audits as automation SME.