Site Engineering Manager, Manufacturing (Isotopes)

Novartis Group Companies; Indianapolis (IN); On-site; USD 114,000 - 212,000; Full time

Benefits offered by this job

Health, Life & Disability benefits

401(k) with company match

Paid time off

Job summary

Novartis Group of Companies in Indianapolis, IN, seeks a Site Engineering Manager to lead process engineering and maintenance in a regulated GMP environment. You will drive reliability initiatives, capital projects, and asset-management programs while partnering across Quality, Automation, Supply Chain and Operations to ensure safe, compliant manufacturing operations.

You will mentor engineers, lead investigations and change controls, and contribute to audits and regulatory readiness.

Qualifications

• Bachelor's degree in Engineering or related field.
• Minimum 5 years in engineering, maintenance, reliability or related in regulated manufacturing.
• 3+ years leading technical teams in a cGMP environment.
• Proficient knowledge of FDA regulations and GMP systems.
• Willingness to travel up to 10%.

Responsibilities

• Provide strategic and day-to-day leadership for Process Engineering and Maintenance.
• Coach and develop engineers and maintenance staff while remaining hands-on when needed.
• Ensure equipment safety, compliance, qualification, and reliability; manage maintenance programs.
• Drive reliability strategies to reduce downtime and improve process performance.
• Oversee commissioning, qualification, validation, and lifecycle documentation.

Skills

Leadership

Regulatory compliance

Process engineering

Maintenance management

FDA regulations

Education

Bachelor's degree in Engineering

Job description

Job Description Summary

Location: Indianapolis, Indiana
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.

Job Description

Key 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.

Essential 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.

The salary for this position is expected to range between $114,100 and $211,900 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

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, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$114,100.00 - $211,900.00

Skills Desired

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