GMP API Project Engineer: Isolators & Equipment Lead

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

Job summary

Novartis Farmacéutica is seeking a Sr Project Engineer to drive capital initiatives in Indianapolis, providing hands-on engineering support from design through execution within a GMP environment. The role requires cross-functional leadership and strong regulatory knowledge to ensure compliant equipment qualification and lifecycle management of API manufacturing systems.

The candidate will lead design, installation, and qualification activities, manage change control, and support regulatory

Qualifications

• Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering.
• 8+ years of relevant experience within the pharmaceutical industry in lieu of a degree.
• Experience supporting API and/or finish drug product manufacturing.
• Strong expertise with Hot cells / Isolator Containment systems.
• In-depth knowledge of FDA regulations and GMP requirements.
• Experience leading equipment qualification, validation strategies, and change management.
• Strong technical writing skills for regulated engineering documentation.

Responsibilities

• Support project planning and procurement for capital initiatives.
• Lead design, installation, qualification, and lifecycle support of Isolator Containment systems for API manufacturing.
• Serve as SME for new equipment supporting API expansion capital project.
• Own equipment change management to maintain validated state and GMP compliance.
• Investigate equipment/process deviations and perform root cause analysis.

Skills

Project management

Regulatory compliance

Technical writing

Cross‑functional leadership

Problem solving

Education

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

8+ years of relevant experience in lieu of degree

Job description

Novartis Farmacéutica is seeking a Sr Project Engineer to drive capital initiatives in Indianapolis, providing hands-on engineering support from design through execution within a GMP environment. The role requires cross-functional leadership and strong regulatory knowledge to ensure compliant equipment qualification and lifecycle management of API manufacturing systems.

The candidate will lead design, installation, and qualification activities, manage change control, and support regulatory