Sr. Engineer, MS&T – Aseptic Drug Product

Novartis•Durham, CA

2d•$114,100 - $211,900•Onsite

About The Position

As Sr. Engineer, Manufacturing Science and Technology – Aseptic Drug Product, you will provide technical leadership for aseptic manufacturing operations, drive process performance, and support the introduction of new products and technologies. Working with Manufacturing, Quality, Engineering, and global partners, you will help address complex challenges, lead continuous improvement initiatives, and support the reliable supply of high-quality products. The position is based onsite in Durham, North Carolina. Novartis is unable to provide 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; alternatively, 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 within a regulated environment.
Hands-on experience with aseptic fill-finish operations and sterile drug product manufacturing.
Experience supporting Tech 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.

Nice To Haves

Applied statistics
Change controls
Cleaning validations
Data analytics
Emotional resilience
Good documentation practices
Health, Safety, and Environment (HSE) policy
Manufacturing processes
Manufacturing production
Manufacturing technologies
Operational excellence
Process control
Process validation
Quality compliance
Regulatory compliance
Risk management
Technical leadership
Technology transfer

Responsibilities

Lead 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 CQAs and 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 Tech Transfer activities and support successful product commercialization.
Drive OPEX initiatives and foster a culture of continuous improvement, quality, and manufacturing excellence.