Aseptic MS&T Engineer — Process Performance Lead

Healthcare Businesswomen’s Association; United States; On-site; USD 114,000 - 212,000; Full time

Benefits offered by this job

Health, life and disability benefits

401(k) with company match

Generous time off

Job summary

Novartis is seeking a Sr. Engineer, Manufacturing Science and Technology – Aseptic Drug Product, to lead process performance, support new product introductions, and drive continuous improvement in an on-site Durham, NC facility.

You will work with Manufacturing, Quality, Engineering, and global partners to ensure reliable supply of high-quality sterile products, with a focus on advancing aseptic manufacturing and tech transfer initiatives.

Qualifications

• Bachelor's degree in Biochemistry, Chemical Engineering, or Bioengineering with 6+ years biopharma manufacturing experience.
• Master's degree with 4+ years, or Doctorate with 2+ years of experience.
• GMP biopharmaceutical manufacturing experience in a regulated environment.
• Hands-on aseptic fill-finish operations experience.
• Experience with Tech Transfer, process validation, lifecycle management, or process improvements.
• Knowledge of global GMP regulations and quality compliance expectations.
• Strong analytical, writing, communication and cross-functional collaboration skills.
• Ability to lead technical initiatives within cross-functional teams.

Responsibilities

• Lead CPV activities by analyzing process data and driving improvements.
• MS&T technical lead for investigations, root cause analysis and issue resolution.
• Partner with Manufacturing to support production schedules and GMP compliance.
• Monitor CQAs and CPPs for consistent quality and process control.
• Identify and implement process improvements to enhance reliability and efficiency.
• Support the introduction of new equipment, systems and processes.
• Create and maintain process change documentation with Engineering, Manufacturing and Validation.
• Provide technical expertise for remediation, project deliverables and assessments.
• Collaborate on Tech Transfer with Development and site partners.
• Drive OPEX and foster continuous improvement, quality and manufacturing excellence.

Skills

Analytical skills

Data-driven decisions

Cross-functional collaboration

Technical writing

Leadership

Education

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

Master's degree in a related field

Doctorate in a related field

Job description

Novartis is seeking a Sr. Engineer, Manufacturing Science and Technology – Aseptic Drug Product, to lead process performance, support new product introductions, and drive continuous improvement in an on-site Durham, NC facility.

You will work with Manufacturing, Quality, Engineering, and global partners to ensure reliable supply of high-quality sterile products, with a focus on advancing aseptic manufacturing and tech transfer initiatives.