Impactful Aseptic Drug Product MS&T Engineer

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

Benefits offered by this job

Health benefits

401(k) with company match

Equity awards eligibility

Job summary

Novartis in Durham, NC is seeking an Engineer, Manufacturing Science & Technology (MS&T) – Aseptic Drug Product to support and improve aseptic fill-finish operations. You will partner with technical, quality, and manufacturing teams to ensure reliable supply, quality, and ongoing operational excellence in a collaborative, patient-focused environment.

The role involves analyzing process data, leading investigations, supporting tech transfer, and driving continuous improvements across

Qualifications

• Degree in Biochemistry, Chemical Engineering, Bioengineering or related field with 4+ years of biopharmaceutical GMP manufacturing experience including aseptic fill-finish; or MS with 2+ years in aseptic fill-finish/engineering.
• Knowledge of GMPs, pharma regulations, validation and qualification principles.
• Experience in aseptic drug product manufacturing, MS&T, process engineering or related technical operations.
• Strong technical writing to develop accurate and compliant documentation.
• Proven ability to collaborate across cross-functional teams and communicate with diverse stakeholders.
• Ability to travel up to 10%.

Responsibilities

• Monitor and analyze process performance data to support verification and product quality.
• Lead technical investigations and provide scientific expertise to resolve process challenges.
• Trend CQAs and process parameters to identify risks and drive improvements.
• Support technology transfer 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, inspection-ready environment.
• Collaborate with Manufacturing to troubleshoot production issues and ensure reliable supply.
• Support process changes 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 and remediation initiatives.

Skills

Biochemistry

Chemical Engineering

MS&T

Aseptic fill-finish

GMP manufacturing

Technical writing

Cross-functional collaboration

Education

Bachelors in Biochemistry/Chemical Eng/Bioengineering

MS in related field

Job description

Novartis in Durham, NC is seeking an Engineer, Manufacturing Science & Technology (MS&T) – Aseptic Drug Product to support and improve aseptic fill-finish operations. You will partner with technical, quality, and manufacturing teams to ensure reliable supply, quality, and ongoing operational excellence in a collaborative, patient-focused environment.

The role involves analyzing process data, leading investigations, supporting tech transfer, and driving continuous improvements across