Senior Automation Leader, Gene Therapy IT/OT Operations

NCBiotech; Durham (NC); On-site; USD 114,000 - 212,000; Full time

Job summary

Novartis is seeking a Sr. Manager, Automation – GTx Lead in Durham, NC to drive automation strategy and lead a high-performance team supporting IT/OT and automation systems in a GMP manufacturing environment.

You will own change controls, CAPAs, and regulatory inspections readiness, mentor engineers, and collaborate across Engineering, Manufacturing, Quality, and Technical Operations to enable reliable, compliant production of advanced therapies.

Qualifications

• Bachelor's degree in Engineering or related field with 9+ years of IT/OT and automation experience.
• Experience with DCS, PLC, SCADA, MES and Historian systems in regulated manufacturing.
• Proven ability to design, operate, maintain, and retire computerized systems in GMP environments.
• Strong leadership for 24/7 operations and cross-functional collaboration.

Responsibilities

• Lead design, implementation, and support of manufacturing automation systems.
• Drive CI initiatives to improve automation performance and reliability.
• Own site automation strategies aligned with global Novartis standards.
• Mentor and develop automation engineers for 24/7 operations.
• Establish KPIs to maximize system reliability and operations excellence.
• Own change controls and CAPAs to drive compliance.
• Lead deviation investigations and provide SME for root cause.
• Support regulatory inspections and audits as automation SME.
• Collaborate with Engineering, Manufacturing, Quality, and Operations on site initiatives.

Skills

Leadership

Cross-functional collaboration

Problem solving

Regulatory understanding

Communication

Education

Bachelor's degree in Engineering or related field

Tools

DCS

PLC

SCADA

MES

Historian systems

CMMS

Building Management Systems

Microsoft Office

Job description

Novartis is seeking a Sr. Manager, Automation – GTx Lead in Durham, NC to drive automation strategy and lead a high-performance team supporting IT/OT and automation systems in a GMP manufacturing environment.

You will own change controls, CAPAs, and regulatory inspections readiness, mentor engineers, and collaborate across Engineering, Manufacturing, Quality, and Technical Operations to enable reliable, compliant production of advanced therapies.