Sr Project Engineer

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

Job Description Summary

In this role, you will work crossfunctionally 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

Job Description

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.

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.

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 and 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 [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$93,800.00 - $174,200.00

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.

Skills Desired

Business Continuity, Change Control, Cost Management, Data Analytics and Digital, Engineering Technical Expertise, GDP Knowledge, gmp knowledge, HSE Knowledge, Knowledge Of Relevant Tools And Systems, Manufacturing Process (Production), Operational Excellence, Quality Compliance, Resilience and Risk Management, Total Productive Maintenance