Sr Project Engineer

Novartis; Indianapolis (IN); On-site; USD 93,800 - 174,200; Full time

Benefits offered by this job

Performance-based cash incentive

Comprehensive benefits package

401(k) with company contribution

Generous time off packages

Job summary

Novartis in Indianapolis, Indiana is seeking an Engineering professional to support capital initiatives and improve isolator containment systems. The role includes project planning, regulatory compliance support, and hands-on engineering from design through execution. Candidates should have a Bachelor's in Engineering and 5+ years in the pharmaceutical industry. The position offers a competitive salary of $93,800 to $174,200, performance incentives, and comprehensive benefits including 401(k) with company match.

Qualifications

• 5+ years of relevant experience in the pharmaceutical industry, or 8+ years in lieu of a degree.
• Extensive experience supporting API and/or finished drug product manufacturing.
• Experience leading equipment qualification and change management.

Responsibilities

• Support internal and external audits.
• Lead design, installation, and lifecycle support of manufacturing equipment.
• Own equipment change management for compliance.

Skills

Leadership of cross-functional teams

Knowledge of FDA regulations

Technical writing skills

Problem-solving skills

Organizational skills

Experience with Hot cells / Isolator systems

Education

Bachelor's degree in Chemical, Electrical, or Mechanical Engineering

Job description

Summary

In this role, you will work cross‑functionally to support the delivery of capital initiatives, continuous improvements/ upgrades to isolator containment systems, and the implementation of new manufacturing technologies within a GMP-regulated environment. Responsibilities include contributing to project planning, leading assigned workstreams, supporting regulatory compliance, and providing hands‑on engineering support from design through execution.

Location

Onsite

Accountabilities

• Support internal and external audits.
• Prepare project procurement plan, perform project tendering and procurement.
• Lead design, installation, qualification, and lifecycle support of Isotopes API manufacturing equipment.
• Serve as subject matter expert for new equipment supporting the API expansion capital project.
• Own equipment change management to maintain validated state and Good Manufacturing Practice compliance.
• Investigate equipment and process deviations, performing root cause analysis and implementing corrective and preventive actions.
• Support regulatory inspections and internal audits as engineering subject matter expert.

Salary Details

The salary for this position is expected to range between $93,800 and $174,200 per year. The final salary offered is determined based on factors such as 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.

Essential Requirements

• Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering
• 5+ years of relevant experience with the pharmaceutical industry, or 8+ years of relevant experience within the pharmaceutical industry in lieu of a degree.
• Extensive experience supporting API and/or finish drug product manufacturing.
• Strong expertise with Hot cells / Isolator Containment systems.
• In‑depth knowledge of FDA regulations and Good Manufacturing Practice (GMP) requirements.
• Experience leading equipment qualification, validation strategies, and change management.
• Strong technical writing skills for regulated engineering documentation.
• Ability to lead cross‑functional teams and manage complex capital initiatives.
• Excellent communication, organizational, and problem‑solving skills.

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.