Novartis
Site Engineering Manager, Manufacturing (Isotopes)
$114K–$212K
Indianapolis · Manager · Full-time · Posted Oct 6, 2026
- Experience
- Minimum 5 years of relevant experience; minimum 3 years of people leadership experience.
- Education
- Bachelor's degree in Engineering, Computer Science, Automation, or a related technical field.
About the job
Leads engineering and maintenance for a GMP isotope manufacturing site, ensuring equipment reliability, compliance, and manufacturing readiness while developing technical teams and overseeing improvement initiatives.
What you'll do
- Lead Process Engineering and Maintenance teams and oversee equipment maintenance, asset management, and reliability programs.
- Direct equipment engineering, commissioning, qualification, validation, investigations, and corrective actions to maintain safe, compliant, reliable operations.
- Manage engineering budgets, contractors, service agreements, procurement, and inspection readiness; partner with site functions and regulators.
What they ask for
- Bachelor's degree in Engineering, Computer Science, Automation, or a related technical field.
- At least 5 years of relevant experience in regulated manufacturing, including engineering, maintenance, reliability, process, or equipment work.
- At least 3 years of people leadership experience managing and developing technical teams in a cGMP environment.
- In-depth knowledge of FDA regulations, Title 21 CFR Part 11, GAMP5, and GMP systems.
Pay
$114,100.00 - $211,900.00 USD base salary
Tools
Title 21 CFR Part 11, GAMP5
Model-written summary · the original posting is authoritative