Job Description Summary#LI-Onsite
Location: Denton, TX, USA
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.
Job DescriptionKey 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
Essential 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.)
Desirable Requirements- 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
The salary for this position is expected to range between $138,600 and $257,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
Salary Range$138,600.00 - $257,400.00
Skills DesiredCapital Expenditure, Change Management, Critical Thinking, Data Analytics and Digital, Decision Making, Efficiency, Engineering Operations Management, Engineering Technical Expertise, Flexibility (Inactive), GDP Knowledge, gmp knowledge, HSE Knowledge, Leadership, Manufacturing Process (Production), operational effectiveness, Problem Solving, Project Management, Quality Compliance, Resilience and Risk Management, Resource Planning and Forecasting, Stakeholder Management, Vendor Management
