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Sr. Manager, Automation – GTx Lead

Novartis

Durham, NCOnsitePosted 53 days ago$114,100 - $211,900/year
Full TimeSenior LevelManufacturing & CMCPharmaceutical
Original posting ↗

Summary

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.

Job description

Key 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.

Essential 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.

Requirements

  • Bachelor's degree in Engineering or a related field
  • 9+ years of experience across IT/OT and automation platforms
  • Strong expertise with DCS, PLC, SCADA, MES, Historian systems, and process equipment
  • Experience with 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 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

Benefits

  • Health benefits
  • Life insurance
  • Disability benefits
  • 401(k) with company contribution and match
  • Performance-based cash incentive
  • Annual equity awards
  • Vacation
  • Personal days
  • Holidays

Company overview

Novartis is a global pharmaceutical company headquartered in Basel, Switzerland, dedicated to reimagining medicine to improve and extend people's lives. As an innovative medicines company, Novartis focuses on developing high-value treatments that address society's greatest disease burdens through technology leadership in research and development. The company operates across five core therapeutic areas: cardiovascular, renal and metabolic diseases; immunology; neuroscience; oncology; and hematology. With a workforce of approximately 75,883 employees worldwide, Novartis reaches nearly 300 million patients across 118 countries. The company leverages advanced technology platforms including targeted protein degradation, cell therapy, gene therapy, radioligand therapy, and xRNA to develop breakthrough treatments. Novartis maintains a strong portfolio of oncology drugs and generics while continuously expanding its pipeline through strategic acquisitions and internal research. The company's commitment extends beyond drug development to ensuring global access to medical innovations through novel access approaches and patient assistance programs.

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