Engineering System & Technology Lead

Band

Level 5

 

Job Description Summary

#LI-Onsite
Location: Indianapolis, Indiana

At Novartis, we are pioneering the future of cancer treatment through Radioligand Therapy (RLT) - a powerful fusion of nuclear medicine and precision oncology. As we expand our global RLT manufacturing footprint, we are seeking passionate, purpose-driven individuals to join our mission of delivering life-changing therapies to patients around the world.

The Engineering System and Technology Lead is responsible for overseeing and optimizing engineering systems and technologies within an aseptic manufacturing environment. This role focuses on leveraging innovative solutions to enhance efficiency, reliability, and compliance. You will provide expertise in system design, integration, automation technologies, and engineering processes while adhering to industry’s best practices and regulatory standards. You will also be responsible for team leadership, project facilitation, and driving performance to meet platform and business objectives. Throughout the design process (Conceptual phase through FAT completion), the Engineering System Lead ensures timely progress, quality adherence, and integration of new technologies into the manufacturing environment.

 

Job Description

Key responsibilities:

• Identify potential vendors that meet technical, regulatory, and business requirements. Evaluate vendor capabilities in terms of technology portfolio, cost-effectiveness, reliability, and support availability. Support collection and assessment of vendor proposals and contract negotiation.
• Ensure alignment between vendor schedules and project timelines, identifying and addressing delays or deviations. Establish clear expectations for deliverables, timelines, and responsibilities.
• Build vendor relationships. Collaborate with vendors to validate preliminary and detailed design documents for the technology/system.
• Engage with cross-functional teams (e.g. Manufacturing Operations, Quality, Automation, Safety) to define comprehensive requirements for the new technology.
• Perform GMP risk assessments to identify potential challenges and mitigation strategies associated with integrating the new technology into the production environment.
• Support automation architecture development and integration into Novartis infrastructure and process control standards. Support consumable kit and material design elements incorporated for use within the equipment design.
• Oversee the creation and revision of technical documents such as P&IDs, wiring diagrams, user manuals, and functional specifications.
• Oversee the design and build of the technology to ensure specifications are adhered to and timelines are maintained
• Collaborate with the vendor to develop test plans and protocols (e.g., Factory Acceptance Testing [FAT], Site Acceptance Testing [SAT]) based on risk assessment and validation requirements. Organize and lead teams to observe FAT at the vendor’s site, ensuring the technology performs as expected under simulated manufacturing conditions.
• Support efforts to prepare the manufacturing site for installation, including organizing utilities, infrastructure modifications, and auxiliary system requirements. Work closely with vendors, contractors, and internal teams to ensure proper installation, checks, and alignment with setup requirements for startup.

Essential Requirements:

• B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with 7+ years of experience providing design, maintenance, automation, engineering, or equivalent support within the pharmaceutical, biotechnology, or related GMP industry, including Drug Substance, Aseptic Filling line, and packaging experience.
• 5+ years of supervisory experience leading a diverse team of regular full time and contract Engineering resources  
• Proven skills in project management, problem solving, negotiating and influencing
• Ability to adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.)
• Proficient in MS Office suite applications, Building Management Systems, and Computerized Maintenance Management Systems (CMMS) and similar GMP systems.

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Desirable Requirements:

• Training in radiochemistry or radio pharmacy
• Radiation safety education

 

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expres