Site Engineering Manager, Manufacturing (Isotopes)

Novartis•Indianapolis, IN

2d•Onsite

About The Position

Imagine leading the engineering strategy behind a state-of-the-art radioligand therapy isotope manufacturing facility and helping deliver life-changing medicines to patients around the world. As the Site Engineering Manager, you will play a critical leadership role in ensuring equipment reliability, operational excellence, and manufacturing readiness across a highly regulated GMP environment. This is an exciting opportunity to build and develop a high-performing technical team, drive innovative engineering solutions, lead key capital and equipment improvement initiatives, and partner across Operations, Quality, Automation, Supply Chain, and other site functions to support safe, compliant, and reliable manufacturing operations.

Requirements

Bachelor's degree in Engineering, Computer Science, Automation, or a related technical field.
Minimum 5 years of engineering, maintenance, reliability, process, or equipment experience within the chemical, pharmaceutical, biotechnology, or other regulated manufacturing industry.
Experience hiring, leading, and developing technical resources in a cGMP environment, including a minimum of 3 years of people leadership experience managing and developing technical teams.
In-depth knowledge of FDA regulations, Title 21 CFR Part 11, GAMP5, and GMP systems.
Strong written and verbal communication skills with the ability to communicate equipment status, risks, priorities, and recommendations to diverse stakeholders.
Ability to travel up to 10% as required.

Nice To Haves

Business Continuity
Cost Management
Decision Making
Operational Excellence
Problem Solving
Project Management
Quality Compliance
Risk Management
Stakeholder Management
Vendor Management

Responsibilities

Provide strategic and day-to-day leadership for the Process Engineering and Maintenance departments supporting manufacturing process equipment, including applicable QC-adjacent equipment.
Coach and develop engineers, maintenance professionals, reliability resources, and external service providers while remaining directly engaged in equipment troubleshooting, investigations, execution, and recovery when needed.
Ensure equipment remains safe, compliant, qualified, reliable, and fit for intended use while owning site maintenance and asset-management programs, including preventive, predictive, and corrective maintenance activities.
Drive equipment reliability strategies to improve performance and reduce unplanned downtime.
Lead process and equipment engineering initiatives that improve process capability, equipment performance, throughput, yield, safety, product quality, and manufacturability.
Provide governance and oversight for commissioning, qualification, and validation activities, including lifecycle documentation, risk-based qualification, periodic review, requalification, and maintenance of the validated state.
Lead engineering investigations, deviations, change controls, corrective and preventive actions, and technical risk assessments, ensuring timely closure and sustainable corrective actions.
Maintain continuous inspection readiness for Engineering and Maintenance; serve as the site engineering subject matter expert during internal audits, health authority inspections, and regulatory commitments.
Manage departmental operating and capital budgets, contractor performance, technical service agreements, and procurement activities to deliver compliant, cost-effective engineering support.