Senior Engineer, MS&T

Novartis • Durham, NC

18h • Onsite

About The Position

Step into a high-impact role where your expertise will directly shape the delivery of life-saving therapies. As a key member of Manufacturing Science and Technology, you’ll lead process improvements and drive innovation in sterile drug product manufacturing, partnering cross-functionally to ensure quality, efficiency, and reliability. This is your opportunity to solve complex challenges, influence production outcomes, and play a critical role in bringing medicines to patients.

Requirements

• Bachelor of Science degree with 6 years, Master of Science with 4 years, or PhD with 2 years of biopharmaceutical manufacturing experience
• Strong experience supporting GMP drug product manufacturing environments, including aseptic processing and fill/finish operations
• Proven ability to analyze data and apply scientific principles to solve complex process issues
• Excellent written and verbal communication skills with strong technical writing capability
• Demonstrated ability to collaborate effectively across cross-functional teams
• Familiarity with global regulatory requirements for drug products, validation, and qualification
• Ability to manage multiple priorities and contribute to continuous improvement initiatives

Nice To Haves

• Applied Statistics
• Change Control
• Data Analytics and Digital
• GDP Knowledge
• gmp knowledge
• HSE Knowledge
• Manufacturing Process
• Manufacturing Production
• Manufacturing Technologies
• Operational Excellence
• Process and Cleaning Validation
• Process Control
• Quality Compliance
• Regulatory Compliance
• Resilience and Risk Management
• Technical Leadership
• Technology Transfer

Responsibilities

• Lead process investigations to resolve manufacturing issues and drive continuous improvements
• Analyze process verification data to identify trends and ensure consistent product quality
• Partner with manufacturing to meet production schedules and maintain reliable drug supply
• Monitor critical quality attributes and process parameters to control variability and drift
• Implement process improvements in collaboration with operations and engineering teams
• Support startup and qualification of new equipment, systems, and manufacturing processes
• Document and manage updates to manufacturing processes in compliance with quality standards
• Provide technical expertise for projects, including remediation and process enhancement initiatives
• Support technology transfer to ensure seamless transition into compliant GMP manufacturing
• Collaborate with Quality to maintain a compliant and inspection-ready production environment

Benefits

• health
• life and disability benefits
• 401(k) with company contribution and match
• generous time off package including vacation, personal days, holidays and other leaves

What This Job Offers

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