Drimva

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

First seen Oct 28, 2026 · Last verified Nov 5, 2026 (UTC)