Sr. Engineer, MS&T – Aseptic Drug Product

Novartis•Durham, CA

2d•$114,100 - $211,900•Onsite

About The Position

The Sr. Engineer, Manufacturing Science and Technology – Aseptic Drug Product provides technical leadership for aseptic manufacturing operations, drives process performance, and supports the introduction of new products and technologies. The role works closely with Manufacturing, Quality, Engineering, and global partners to resolve complex challenges, lead continuous improvement, and help ensure a reliable supply of high-quality products. This is an onsite position located in Durham, North Carolina. Novartis is unable to offer relocation support for this role.

Requirements

Bachelor's degree in Biochemistry, Chemical Engineering, Bioengineering, or a related technical field with 6 or more years of biopharmaceutical manufacturing experience; or a master's degree with 4 or more years of experience; or a doctorate with 2 or more years of experience.
Proven experience supporting GMP biopharmaceutical manufacturing operations in a regulated environment.
Hands-on experience with aseptic fill-finish operations and sterile drug product manufacturing.
Experience supporting technology transfer, process validation, lifecycle management, or manufacturing process improvements.
Working knowledge of global GMP regulations, validation requirements, and quality compliance expectations.
Strong analytical skills, including the ability to interpret process data, identify trends, and drive data-based decisions.
Excellent technical writing, communication, and cross-functional collaboration skills.
Demonstrated ability to lead technical initiatives and contribute effectively within cross-functional teams.

Responsibilities

Lead Continued Process Verification (CPV) activities by analyzing process data, identifying trends, and driving process performance improvements.
Serve as the MS&T technical lead for manufacturing investigations, root cause analysis, and issue resolution.
Partner with Manufacturing to support production schedules, commercial supply, and compliance with GMP requirements.
Monitor and trend critical quality attributes (CQAs) and critical process parameters (CPPs) to ensure consistent product quality and process control.
Identify, evaluate, and implement process improvements that enhance reliability, efficiency, and performance.
Support the introduction of new equipment, systems, and manufacturing processes through startup and implementation activities.
Author and support process change documentation in collaboration with Engineering, Manufacturing, and Validation teams.
Provide technical expertise for remediation efforts, project deliverables, technical assessments, and process reports.
Collaborate with Development and site partners to execute technology transfer activities and support successful product commercialization.
Drive operational excellence (OPEX) initiatives and foster a culture of continuous improvement, quality, and manufacturing excellence.