Engineer, MS&T – Aseptic Drug Product

Novartis • Durham, NC

9d • Onsite

About The Position

This position will be located in Durham, NC and will be an onsite role. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. As an Engineer, Manufacturing Science & Technology (MS&T) – Aseptic Drug Product, you will play a critical role in supporting and improving aseptic fill-finish manufacturing operations, partnering across technical, quality, and manufacturing teams to ensure reliable product supply, operational excellence, and the highest standards of quality. This is an opportunity to apply your scientific and engineering expertise in a collaborative environment where your contributions directly impact patients while helping shape the future of advanced manufacturing at Novartis.

Requirements

• Bachelor’s degree in Biochemistry, Chemical Engineering, Bioengineering, or a related technical field with 4+ years of biopharmaceutical GMP manufacturing experience, including aseptic fill-finish operations; 3+ years of direct Novartis Gene Therapies experience with aseptic fill-finish operations; or a Master of Science degree in a related technical field with 2+ years of relevant aseptic fill-finish or engineering experience.
• Knowledge of GMP requirements, pharmaceutical manufacturing regulations, and validation and qualification principles.
• Experience supporting aseptic drug product manufacturing, MS&T, process engineering, or related technical operations.
• Strong technical writing skills with the ability to develop accurate and compliant documentation.
• Proven ability to collaborate effectively across cross-functional teams and communicate with diverse stakeholders.
• Ability to travel up to 10% as required.

Nice To Haves

• Continual Improvement Process
• Manufacturing Production
• Operational Excellence
• Process Control
• Regulatory Compliance

Responsibilities

• Monitor and analyze process performance data to support continued process verification and product quality.
• Lead technical investigations and provide scientific expertise to resolve manufacturing process challenges.
• Trend critical quality attributes and process parameters to identify risks and drive improvements.
• Support technology transfer activities for new products and processes into commercial manufacturing.
• Identify and implement continuous improvement opportunities that enhance operational performance.
• Partner with Quality teams to maintain a compliant and inspection-ready manufacturing environment.
• Collaborate with Manufacturing to troubleshoot production issues and ensure reliable product supply.
• Support process changes and improvements with cross-functional Engineering, Validation, and Operations teams.
• Contribute to the startup and implementation of new equipment, software, and manufacturing processes.
• Provide technical support for strategic projects, remediation initiatives, and process optimization efforts.

Benefits

• health, life and disability benefits
• a 401(k) with company contribution and match
• a variety of other benefits
• generous time off package including vacation, personal days, holidays and other leaves
• performance-based cash incentive
• eligibility to be considered for annual equity awards

What This Job Offers

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