Site Engineering Manager, Manufacturing (Isotopes)

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.

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