Sr. Engineer, MS&T – Aseptic Drug Product

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:

• Bachelors degree in Biochemistry Chemical Engineering Bioengineering or a related technical field with 6 years of biopharmaceutical manufacturing experience; Masters 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 $114100 and $211900 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 addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.

#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 or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$114100.00 - $211900.00

Skills Desired

Applied Statistics Manufacturing Production Manufacturing Technologies Operational Excellence Process Control Quality Compliance Regulatory Compliance Technical Leadership Technology Transfer