Senior MS&T Engineer — Aseptic Drug Product (Onsite Durham)

Novartis AG; North Carolina; On-site; USD 114,000 - 212,000; Full time

Job summary

Novartis in Durham, NC is seeking a Sr. Engineer, Manufacturing Science and Technology – Aseptic Drug Product, onsite to lead process improvements and technical investigations.

You will partner with Manufacturing, Quality, Engineering, and global teams to ensure reliable supply of high-quality sterile products, driving CPV, tech transfer, validation, and lifecycle management with a focus on continuous improvement.

Qualifications

• Bachelor’s degree in Biochemistry, Chemical Engineering, Bioengineering, or related technical field with 6+ years of biopharmaceutical manufacturing experience; Master’s degree with 4+ years; or Doctorate with 2+ years.
• Proven experience in GMP biopharmaceutical manufacturing operations.
• Hands-on aseptic fill-finish and sterile drug product manufacturing experience.

Responsibilities

• Lead CPV activities by analyzing process data and driving performance improvements.
• Serve as MS&T technical lead for investigations, root cause analysis, and issue resolution.
• Support production schedules, commercial supply, and GMP compliance.
• Monitor CQAs and CPPs to ensure product quality and process control.
• Identify and implement process improvements to enhance reliability and efficiency.
• Support new equipment, systems, and manufacturing process startups.

Skills

Analytical skills

Data-driven decisions

Cross-functional collaboration

Process data interpretation

Education

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

Master's degree (4+ years experience)

Doctorate (2+ years experience)

Tools

GMP regulations

Process validation

Lifecycle management

Job description

Novartis in Durham, NC is seeking a Sr. Engineer, Manufacturing Science and Technology – Aseptic Drug Product, onsite to lead process improvements and technical investigations.

You will partner with Manufacturing, Quality, Engineering, and global teams to ensure reliable supply of high-quality sterile products, driving CPV, tech transfer, validation, and lifecycle management with a focus on continuous improvement.