GMP Automation Leader - Senior Manager, 24/7 Ops

Novartis Group Companies

Durham (NC)

On-site

USD 114,000 - 212,000

Full time

14 days+

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Job summary

Novartis Group of Companies in Durham, NC is seeking a Sr. Manager, Automation - GTx Lead to guide a high‑performing team responsible for IT/OT and automation systems that enable compliant, efficient manufacturing.

You will shape automation strategy and drive continuous improvement across Engineering, Manufacturing, Quality, and Technical Operations in a GMP setting. You will lead critical automation initiatives, own change controls, mentor engineers, and collaborate with cross-functional teams

Qualifications

Bachelor's degree in Engineering or related field with 9+ years IT/OT and automation experience.
Experience designing, operating, modifying, maintaining, and retiring computerized systems in regulated manufacturing.
Strong collaboration across Quality Engineering, Quality Assurance, Validation, Engineering, and Manufacturing.
Knowledge of FDA regulations, cGMP, and health, safety, environmental standards.
Proven leadership of technical teams in 24/7 manufacturing environments.

Responsibilities

Lead design, implementation, maintenance, and support of manufacturing automation systems.
Drive continuous improvement to enhance automation performance and reliability.
Execute site automation strategies aligned with Novartis standards.
Own computerized systems supporting critical manufacturing processes.
Lead, mentor, and develop automation engineers for 24/7 operations.
Establish and improve KPIs for reliability and operational excellence.
Own change controls and CAPAs to drive compliance and improvement.
Lead automation-related deviation investigations and perform root-cause analysis.
Serve as automation SME during regulatory inspections and audits.
Partner across functions to support new product introductions and site initiatives.