Engineer, MS&T – Aseptic Drug Product

Band

Level 3

Job Description Summary

Are you passionate about advancing sterile manufacturing processes that help deliver life-changing therapies to patients As an Engineer Manufacturing Science & Technology (MS&T) Aseptic Drug Product you will play a critical role in supporting and improving aseptic fill-finish manufacturing operations partnering across technical quality and manufacturing teams to ensure reliable product supply operational excellence and the highest standards of quality. This is an opportunity to apply your scientific and engineering expertise in a collaborative environment where your contributions directly impact patients while helping shape the future of advanced manufacturing at Novartis.

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:

• Monitor and analyze process performance data to support continued process verification and product quality.
• Lead technical investigations and provide scientific expertise to resolve manufacturing process challenges.
• Trend critical quality attributes and process parameters to identify risks and drive improvements.
• Support technology transfer activities for new products and processes into commercial manufacturing.
• Identify and implement continuous improvement opportunities that enhance operational performance.
• Partner with Quality teams to maintain a compliant and inspection-ready manufacturing environment.
• Collaborate with Manufacturing to troubleshoot production issues and ensure reliable product supply.
• Support process changes and improvements with cross-functional Engineering Validation and Operations teams.
• Contribute to the startup and implementation of new equipment software and manufacturing processes.
• Provide technical support for strategic projects remediation initiatives and process optimization efforts.

Essential Requirements:

• Bachelors degree in Biochemistry Chemical Engineering Bioengineering or a related technical field with 4 years of biopharmaceutical GMP manufacturing experience including aseptic fill-finish operations; 3 years of direct Novartis Gene Therapies experience with aseptic fill-finish operations; or a Master of Science degree in a related technical field with 2 years of relevant aseptic fill-finish or engineering experience.
• Knowledge of GMP requirements pharmaceutical manufacturing regulations and validation and qualification principles.
• Experience supporting aseptic drug product manufacturing MS&T process engineering or related technical operations.
• Strong technical writing skills with the ability to develop accurate and compliant documentation.
• Proven ability to collaborate effectively across cross-functional teams and communicate with diverse stakeholders.
• Ability to travel up to 10% as required.

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $89600 and $166400 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.

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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 gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

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 in order to perform the essential functions of a position please send an e-mail to call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Range

$89600.00 - $166400.00

Skills Desired

Continual Improvement Process Manufacturing Production Operational Excellence Process Control Regulatory Compliance