Head of Engineering, Texas (AD level)

NovartisIndianapolis, IN
Onsite

About The Position

Help bring a new Radioligand Therapy manufacturing site to life—building the engineering backbone that enables safe, compliant, reliable operations from day one. As Head of Engineering, you will play a pivotal role in launching a new U.S. manufacturing site, setting direction for engineering and facilities operations from design through commissioning and start-up. As a member of the site leadership team, you will shape the site master plan, oversee capital investments, and build a high-performing engineering organization that ensures inspection-ready operations from day one. This highly visible leadership role offers the opportunity to leave a lasting imprint on patient supply, regulatory success, and the future growth of Novartis’ RLT network.

Requirements

  • Bachelor’s degree in engineering or a related discipline, or equivalent combination of education and relevant experience
  • Minimum of 10 years of progressive engineering experience in US cGMP environments
  • At least 5 years leadership experience of engineering and maintenance in cGMP plant, including facility design aligned to Lean concepts for material, people, and waste flows
  • Strong expertise in pharmaceutical engineering systems, including facilities, utilities, equipment, commissioning, qualification, and lifecycle maintenance
  • Direct involvement with quality regulatory inspections of facilities from major agencies such FDA or EMA
  • Excellent knowledge of engineering standards for buildings, facilities, and equipment in the pharmaceutical industry along with management of construction projects
  • Significant Environment Health and Safety, and GxP / QA experience building an injury and error-free culture with knowledge of multiple compliance areas (corporate governance, financial, quality, environment, safety, etc.)

Nice To Haves

  • Experience supporting radiopharmaceutical, radiochemistry, or sterile drug product manufacturing operations
  • Prior involvement in new site start-up and launch projects, including design through commissioning and qualification

Responsibilities

  • Provide leadership for engineering and facilities operations to enable successful launch of a new RLT manufacturing site
  • Develop and execute the site engineering strategy and five-year Site Master Plan, including capacity, capital investment, and resource planning
  • Build, lead, and develop a high-performing engineering and facilities organization, including succession planning and talent development
  • Ensure facilities, utilities, and equipment are designed, commissioned, qualified, and maintained to meet regulatory and business requirements
  • Lead capital project planning and execution, ensuring delivery on time, within budget, and aligned with site launch milestones
  • Establish and maintain a state of continuous compliance with regulatory requirements, quality standards, and internal policies
  • Partner closely with Quality, Production, Supply Chain, and Health, Safety & Environment leaders to support inspection readiness and operational excellence
  • Drive a strong culture of safety, quality, accountability, and continuous improvement across engineering and facilities operations

Benefits

  • health, life and disability benefits
  • a 401(k) with company contribution and match
  • a variety of other benefits
  • a generous time off package including vacation, personal days, holidays and other leaves
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