Sr. Engineer, MS&T – Aseptic Drug Product

Novartis • Durham, NC

15h • 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 introduction of new products and technologies. The role works closely with Manufacturing, Quality, Engineering, Development, and global partners to solve technical challenges, support continuous improvement, and ensure a reliable supply of high-quality products.

This is an onsite position in Durham, North Carolina. Novartis is unable to offer relocation support.

Requirements

• Bachelor's degree in Biochemistry, Chemical Engineering, Bioengineering, or a related technical field and 6 or more years of biopharmaceutical manufacturing experience; alternatively, a master's degree and 4 or more years of experience, or a doctorate and 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 interpreting process data, identifying trends, and making 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 continuous improvement, quality, and manufacturing excellence.

Benefits

• Performance-based cash incentive.
• Depending on role level, eligibility to be considered for annual equity awards.
• Health benefits.
• Life benefits.
• Disability benefits.
• 401(k) with company contribution and match.
• Vacation, personal days, holidays, and other leaves.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior