Sr Project Engineer (Indianapolis)

This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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

About the Role

Major 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.

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 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.

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 Food and Drug Administration (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.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally.
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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 & 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 [email protected] or call View phone number on apply.placed-app.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.