Sr Manufacturing Technical MES Specialist
Novartis
Summary
Imagine helping bring life-changing cell and gene therapies to patients by transforming how manufacturing operations are executed and documented. As a Sr Manufacturing Technical MES Specialist at Novartis, you will play a critical role in advancing digital manufacturing capabilities through the design, implementation, and optimization of Manufacturing Execution Systems. Working closely with manufacturing, quality, supply chain, and technical teams, you will drive paperless manufacturing solutions, enhance operational efficiency, and ensure the compliant execution of complex production processes. This is an opportunity to shape the future of advanced therapy manufacturing while making a meaningful impact on patients worldwide.
Job description
Key Responsibilities
- Own end-to-end Manufacturing Execution System processes supporting commercial, clinical, and future manufacturing programs.
- Design, configure, test, implement, and continuously improve electronic Master Batch Records and manufacturing workflows.
- Provide Manufacturing Execution System production support and resolve system issues to ensure uninterrupted operations.
- Collaborate with manufacturing, supply chain, quality, technical development, and validation teams to optimize processes.
- Manage Manufacturing Execution System updates, change controls, corrective actions, and documentation revisions to maintain compliance.
- Support system integrations and master data management across enterprise platforms, including laboratory and enterprise resource planning systems.
- Coach and train key users and subject matter experts on batch record design, execution, and best practices.
Essential Requirements
- Bachelor’s degree or higher, or equivalent relevant work experience.
- Minimum 2 to 5 years of Manufacturing Execution System experience, including Master Batch Record design and creation.
- 5 years of experience in a regulated current Good Manufacturing Practice environment, preferred.
- Demonstrated expertise in technical Manufacturing Execution System Master Batch Record design, testing, implementation, and maintenance.
- Knowledge of Manufacturing Execution System interfaces and integrations, including enterprise resource planning and laboratory information management systems.
- Strong business requirements gathering, project management, communication, and documentation skills with exceptional attention to detail.
Requirements
- Bachelor’s degree or higher, or equivalent relevant work experience.
- Minimum 2 to 5 years of Manufacturing Execution System experience, including Master Batch Record design and creation.
- 5 years of experience in a regulated current Good Manufacturing Practice environment, preferred.
- Demonstrated expertise in technical Manufacturing Execution System Master Batch Record design, testing, implementation, and maintenance.
- Knowledge of Manufacturing Execution System interfaces and integrations, including enterprise resource planning and laboratory information management systems.
- Strong business requirements gathering, project management, communication, and documentation skills with exceptional attention to detail.
Benefits
- Health insurance
- Life insurance
- Disability benefits
- 401(k) with company contribution and match
- Vacation
- Personal days
- Holidays
- Performance-based cash incentive
- Annual equity awards
Company overview
Novartis is a global pharmaceutical company headquartered in Basel, Switzerland, dedicated to reimagining medicine to improve and extend people's lives. As an innovative medicines company, Novartis focuses on developing high-value treatments that address society's greatest disease burdens through technology leadership in research and development. The company operates across five core therapeutic areas: cardiovascular, renal and metabolic diseases; immunology; neuroscience; oncology; and hematology. With a workforce of approximately 75,883 employees worldwide, Novartis reaches nearly 300 million patients across 118 countries. The company leverages advanced technology platforms including targeted protein degradation, cell therapy, gene therapy, radioligand therapy, and xRNA to develop breakthrough treatments. Novartis maintains a strong portfolio of oncology drugs and generics while continuously expanding its pipeline through strategic acquisitions and internal research. The company's commitment extends beyond drug development to ensuring global access to medical innovations through novel access approaches and patient assistance programs.