Sr Project Engineer

Novartis•Indianapolis, IN

1d•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.

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.

Nice To Haves

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

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.