Site Engineering Manager, Manufacturing (Isotopes)

About the role

Novartis is looking for a Site Engineering Manager for its radioligand therapy isotope manufacturing facility in Indianapolis, Indiana. You will lead the engineering strategy behind the facility, ensuring equipment reliability, operational excellence and manufacturing readiness in a highly regulated GMP environment, and will build and develop a high-performing technical team.

Key responsibilities

• Lead Process Engineering and Maintenance, covering manufacturing process equipment and QC-adjacent equipment
• Coach and develop engineers, maintenance professionals, reliability resources and external service providers, while staying hands-on with troubleshooting, investigations and recovery
• Own site maintenance and asset-management programs, including preventive, predictive and corrective maintenance
• Drive equipment reliability strategies and lead engineering initiatives that improve process capability, throughput, yield, safety and product quality
• Oversight of commissioning, qualification and validation, including lifecycle documentation, risk-based qualification and requalification
• Lead engineering investigations, deviations, change controls, CAPAs and technical risk assessments
• Serve as engineering subject matter expert during internal audits, health authority inspections and regulatory commitments
• Manage departmental operating and capital budgets, contractors, technical service agreements and procurement

Required profile

• Bachelor's degree in Engineering, Computer Science, Automation or a related technical field
• Minimum 5 years of engineering, maintenance, reliability, process or equipment experience in chemical, pharmaceutical, biotechnology or another regulated manufacturing industry
• At least 3 years of people leadership experience hiring, leading and developing technical teams in a cGMP environment
• Ability to travel up to 10%

Required skills

• In-depth knowledge of FDA regulations, Title 21 CFR Part 11, GAMP5 and GMP systems
• Strong written and verbal communication with stakeholders
• Desired: business continuity, cost management, project management, vendor management and quality compliance

What we offer

• Expected salary range of $114,100 to $211,900 per year, with a performance-based cash incentive and possible annual equity awards
• Health, life and disability benefits, 401(k) with company contribution and match
• Vacation, personal days, holidays and other leaves