Sr. Engineer, MS&T – Aseptic Drug Product

U473 (FCRS = US473) Novartis Innovative Technologies Inc; North Carolina; On-site; USD 114,000 - 212,000; Full time

Job summary

Novartis Innovative Technologies Inc in Durham, NC, seeks a Sr. Engineer, Manufacturing Science and Technology – Aseptic Drug Product, to lead process performance improvements and support tech transfer for sterile products.

Onsite role in Durham with cross-functional collaboration across Manufacturing, Quality, Engineering, and global partners. You will analyze process data, lead investigations, and contribute to robust aseptic fill-finish operations while driving continuous improvement,

Qualifications

• Bachelor's degree in a technical field with 6+ years of biopharmaceutical manufacturing experience or advanced degree with fewer years.
• Hands-on GMP biopharmaceutical manufacturing experience.
• Experience with aseptic fill-finish operations and sterile drug product manufacturing.

Responsibilities

• Lead CPV activities by analyzing process data and driving improvements.
• Serve as MS&T technical lead for investigations and root cause analysis.
• Support production schedules, GMP compliance, and quality targets.
• Monitor CQAs and CPPs to maintain product quality and process control.
• Identify and implement process improvements for reliability and efficiency.
• Support tech transfer and introduction of new equipment and processes.
• Collaborate on process change documentation with Engineering and Validation teams.

Skills

Applied Statistics

Change Controls

Data Analytics

Process Control

Process Validation

Regulatory Compliance

Technical Leadership

Risk Management

Quality Compliance

Manufacturing Processes

Manufacturing Technologies

Operational Excellence

Technology Transfer

Documentation Practices

Education

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

Master's degree with 4+ years experience

Doctorate with 2+ years experience

Job description

Job Description Summary Imagine being at the forefront of delivering life-changing sterile medicines to patients around the world. As Sr. Engineer, Manufacturing Science and Technology – Aseptic Drug Product, you will play a critical role in advancing aseptic manufacturing operations by providing technical leadership, driving process performance, and supporting the successful introduction of new products and technologies. Working closely with Manufacturing, Quality, Engineering, and global partners, you will help solve complex challenges, lead continuous improvement initiatives, and ensure a reliable supply of high-quality products for patients. This is an exciting opportunity to make a meaningful impact in a collaborative environment that values innovation, scientific excellence, and operational excellence.

Job Description Location:

This position will be located in Durham, NC and will be an onsite role. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Key Responsibilities:

• Lead CPV activities by analyzing process data, identifying trends, and driving process performance improvements.
• Serve as the MS&T technical lead for manufacturing investigations, root cause analysis, and issue resolution.
• Partner with Manufacturing to support production schedules, commercial supply, and compliance with GMP requirements.
• Monitor and trend CQAs and CPPs to ensure consistent product quality and process control.
• Identify, evaluate, and implement process improvements that enhance reliability, efficiency, and performance.
• Support the introduction of new equipment, systems, and manufacturing processes through startup and implementation activities.
• Author and support process change documentation while collaborating with Engineering, Manufacturing, and Validation teams.
• Provide technical expertise for remediation efforts, project deliverables, technical assessments, and process reports.
• Collaborate with Development and site partners to execute Tech Transfer activities and ensure successful product commercialization.
• Drive OPEX initiatives and foster a culture of continuous improvement, quality, and manufacturing excellence.

Essential Requirements:

• Bachelor's degree in Biochemistry, Chemical Engineering, Bioengineering, or a related technical field with 6+ years of biopharmaceutical manufacturing experience; Master's degree with 4+ years of experience; or Doctorate degree with 2+ years of experience.
• Proven experience supporting GMP biopharmaceutical manufacturing operations within a regulated environment.
• Hands-on experience with aseptic fill-finish operations and sterile drug product manufacturing.
• Experience supporting Tech Transfer, process validation, lifecycle management, or manufacturing process improvements.
• Working knowledge of global GMP regulations, validation requirements, and quality compliance expectations.
• Strong analytical skills with the ability to interpret process data, identify trends, and drive data-based decisions.
• Excellent technical writing, communication, and cross-functional collaboration skills.
• Demonstrated ability to lead technical initiatives and contribute effectively within cross-functional teams.

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $114,100 and $211,900 annually The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

Salary Range $114,100.00 - $211,900.00

Skills Desired

• Applied Statistics
• Change Controls
• Cleaning Validations
• Data Analytics
• Emotional Resilience
• Good Documentation Practices
• Health, Safety, and Environment (HSE) Policy
• Manufacturing Processes
• Manufacturing Production
• Manufacturing Technologies
• Operational Excellence
• Process Control
• Process Validation
• Quality Compliance
• Regulatory Compliance
• Risk Management
• Technical Leadership
• Technology Transfer

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.

#LI-Onsite EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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