摘要
Location: Durham, NC
Relocation Support: This role is based in Durham, NC. Novartis is unable to offer relocation support: please only apply if accessible.
As a Senior Manager, Engineering – Asset Lifecycle Management, you’ll lead a team of engineers dedicated to ensuring the reliability and performance of cutting-edge biomanufacturing equipment. This is your opportunity to shape the future of cell and gene therapy operations by driving asset strategy, optimizing equipment lifecycle, and championing continuous improvement. If you're passionate about innovation, leadership, and making a tangible impact on patient-ready therapies, this role is your next big move.
About the Role
Key Responsibilities:
- Lead and mentor a team of site-based engineers to ensure reliable operation of all process and lab equipment.
- Define and evolve maintenance strategies for process, utility, QC, and TRD equipment to maximize uptime and compliance.
- Execute asset lifecycle management practices aligned with global Novartis standards and industry best practices.
- Drive a data-informed reliability program to ensure asset availability, performance, and validated state.
- Maintain ownership of master data for all site equipment, ensuring accuracy and regulatory readiness.
- Develop, track, and improve KPIs to monitor system reliability and identify areas for improvement.
- Plan and prioritize recapitalization of critical assets to support long-term operational sustainability.
- Lead change management and CAPA initiatives to enhance equipment reliability and reduce downtime.
- Serve as subject matter expert in deviation investigations and regulatory audits involving equipment.
- Support capital projects by developing equipment specifications and evaluating facility fit for new products.
Essential Requirements:
- Bachelor of Science degree in Engineering or other relevant degree with 9+ years of experience across process engineering, maintenance, qualification, and continuous improvement for process equipment in biotechnology operations.
- Proven expertise in maintaining, modifying, and retiring production equipment in a regulated environment.
- Experience leading engineering teams in a GMP-regulated biotechnology or pharmaceutical environment.
- In-depth knowledge of FDA regulations, cGMP standards, and environmental health and safety protocols.
- Proficiency in MS Office, Building Management Systems, and Computerized Maintenance Management Systems (CMMS).
Desirable Requirements:
- Strong collaboration skills with cross-functional teams including Quality, Validation, and Operations.
- Familiarity with strategic planning for facility and equipment master plans.
Novartis Compensation and Benefit Summary:
The salary for this position is expected to range between $114,100 and $211,900 per year. 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.
Company will not sponsor visas for this position.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? http://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards
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 & 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 [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.