Sr Project Engineer

Novartis • Indianapolis, IN

4d • Onsite

About The Position

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

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.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees