Sr. Manager, Automation – GTx Lead

NovartisDurham, NC
Onsite

About The Position

Join Novartis and play a pivotal role in advancing next-generation gene therapies through innovative automation leadership. As Sr. Manager, Automation – GTx Lead, you will lead a high-performing team responsible for critical IT/OT and automation systems that enable reliable, compliant, and efficient manufacturing operations. This is an opportunity to shape automation strategy, drive continuous improvement, and influence the future of advanced therapies while collaborating across Engineering, Manufacturing, Quality, and Technical Operations in a fast-paced GMP environment.

Requirements

  • Bachelor's degree in Engineering or a related field with 9+ years of experience across IT/OT and automation platforms.
  • Strong expertise with DCS, PLC, SCADA, MES, Historian systems, and process equipment supporting drug substance and drug product manufacturing.
  • Proven experience designing, operating, modifying, maintaining, and retiring computerized systems in a regulated manufacturing environment.
  • Demonstrated success leading technical teams and supporting complex 24/7 manufacturing operations.
  • Ability to collaborate effectively across Quality Engineering, Quality Assurance, Validation, Engineering, and Manufacturing functions.
  • Strong problem-solving, planning, decision-making, and communication skills.
  • Knowledge of FDA regulations, cGMP requirements, and health, safety, and environmental standards.
  • Proficiency with Microsoft Office, CMMS, Building Management Systems, and related digital tools.

Nice To Haves

  • Business Continuity
  • Cost Management
  • Operational Excellence
  • Project Management
  • Risk Management
  • Stakeholder Management
  • Vendor Management

Responsibilities

  • Lead the design, implementation, maintenance, and support of manufacturing automation systems and process equipment.
  • Drive continuous improvement initiatives to enhance automation performance, reliability, and innovation.
  • Execute site automation strategies aligned with global Novartis standards and best practices.
  • Own and oversee computerized systems supporting critical manufacturing processes.
  • Lead, mentor, and develop a team of automation engineers supporting 24/7 operations.
  • Establish and improve KPIs to maximize system reliability, availability, and operational excellence.
  • Own change controls and CAPAs to drive compliance and continuous improvement.
  • Lead automation-related deviation investigations and provide SME expertise for root cause analysis.
  • Serve as the automation SME during regulatory inspections and internal or external audits.
  • Partner with Engineering, Manufacturing, Quality, and Technical Operations to support new product introductions and site initiatives.

Benefits

  • performance-based cash incentive
  • annual equity awards
  • health, life and disability benefits
  • a 401(k) with company contribution and match
  • generous time off package including vacation, personal days, holidays and other leaves
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