Aseptic Drug Product MS&T Engineer — Process Excellence

Novartis Group Companies; Durham (NC); On-site; USD 90,000 - 166,000; Full time

Job summary

Novartis Group of Companies in Durham, NC seeks an Engineer, Manufacturing Science & Technology (MS&T) – Aseptic Drug Product to advance sterile fill-finish operations. You will partner with technical, quality, and manufacturing teams to ensure reliable product supply, drive improvements, and uphold the highest quality standards in a fast-paced biologics environment.

The role emphasizes process verification, technology transfer, and continuous improvement, with travel up to 10% and an onsite,

Qualifications

• Bachelor's degree in Biochemistry, Chemical Engineering, Bioengineering, or related field with 4+ years of biopharmaceutical GMP manufacturing experience; 3+ years with Novartis Gene Therapies experience; or MS with 2+ years of relevant aseptic fill-finish/engineering experience.
• Knowledge of GMP requirements, pharmaceutical manufacturing regulations, and validation/qualification principles.
• Experience supporting aseptic drug product manufacturing, MS&T, process engineering, or related operations.
• Strong technical writing skills for accurate, compliant documentation.
• Proven ability to collaborate across cross-functional teams and communicate with diverse stakeholders.

Responsibilities

• Monitor and analyze process performance data to support process verification and product quality.
• Lead technical investigations 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 to 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 startup and implementation of new equipment, software, and manufacturing processes.
• Provide technical support for strategic projects, remediation initiatives, and process optimization.

Skills

Continual Improvement Process

Manufacturing Production

Operational Excellence

Process Control

Regulatory Compliance

Education

Bachelor's degree in Biochemistry, Chemical Engineering, Bioengineering, or related technical field

Master of Science in related field

Job description

Novartis Group of Companies in Durham, NC seeks an Engineer, Manufacturing Science & Technology (MS&T) – Aseptic Drug Product to advance sterile fill-finish operations. You will partner with technical, quality, and manufacturing teams to ensure reliable product supply, drive improvements, and uphold the highest quality standards in a fast-paced biologics environment.

The role emphasizes process verification, technology transfer, and continuous improvement, with travel up to 10% and an onsite,