Senior Project Engineer – GMP API Isolator Lead

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

Benefits offered by this job

Comprehensive benefits package

Performance-based cash incentive

Generous time off package

Job summary

A leading pharmaceutical company in Indianapolis seeks an experienced engineer to support capital initiatives and API manufacturing technologies within a GMP-regulated environment. This role involves project planning, audit support, and technical documentation. Applicants should hold a degree in engineering and have extensive experience in the pharmaceutical sector, specifically with isolator containment systems and regulatory compliance. The position offers a competitive salary range of $93,800 to $174,200 annually along with a comprehensive benefits package.

Qualifications

• 5+ years of relevant experience with the pharmaceutical industry, or 8+ years of relevant experience in lieu of a degree.
• Extensive experience supporting API and/or finish drug product manufacturing.
• Strong expertise with Hot cells / Isolator Containment systems.

Responsibilities

• Support internal and external audits.
• Lead design, installation, qualification, and lifecycle support of manufacturing equipment.
• Investigate equipment and process deviations, performing root cause analysis.

Skills

Change Control

Engineering Technical Expertise

Quality Compliance

Data Analytics and Digital

Operational Excellence

Education

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

Job description

A leading pharmaceutical company in Indianapolis seeks an experienced engineer to support capital initiatives and API manufacturing technologies within a GMP-regulated environment. This role involves project planning, audit support, and technical documentation. Applicants should hold a degree in engineering and have extensive experience in the pharmaceutical sector, specifically with isolator containment systems and regulatory compliance. The position offers a competitive salary range of $93,800 to $174,200 annually along with a comprehensive benefits package.