Manufacturing Execution Systems (MES) Specialist
Novartis
Summary
Join Novartis and help shape the future of digital manufacturing through PAS-X MES technology. As an MES Specialist, you will own the design, configuration, implementation, and continuous improvement of PAS-X solutions that support electronic batch records, paperless manufacturing, and GMP-compliant production operations. Working closely with Manufacturing, Quality, Validation, and IT teams, you will play a critical role in ensuring reliable manufacturing execution while advancing operational excellence and helping deliver medicines to patients worldwide.
Job description
Key Responsibilities
- Design, build, test, and maintain PAS-X electronic Master Batch Records and electronic batch records.
- Configure PAS-X workflows, recipes, paperless instructions, and manufacturing process controls.
- Serve as the site PAS-X SME supporting manufacturing operations and shop floor users.
- Troubleshoot MES and PAS-X issues to minimize production disruptions and improve system performance.
- Partner with Manufacturing, Quality, Validation, Automation, and IT teams on MES initiatives.
- Support PAS-X deployments, enhancements, upgrades, qualification activities, and validation batches.
- Maintain MES integrations with SAP, LIMS, OSI PI, 1QEM, and related manufacturing systems.
- Ensure MES activities comply with GMP, FDA, CSV, data integrity, and quality requirements.
- Own or support deviations, CAPAs, change controls, and audit readiness activities.
- Drive continuous improvement of PAS-X design, batch record usability, and manufacturing efficiency.
Essential Requirements
- Bachelor's degree in Engineering, Computer Science, Information Technology, or a related technical field.
- 5+ years of professional experience within pharmaceutical, biotechnology, life sciences, or regulated manufacturing environments.
- 3+ years of experience supporting MES platforms, preferably involving PAS-X and electronic batch records.
- Hands-on experience configuring, developing, maintaining, or enhancing PAS-X MES solutions.
- Demonstrated knowledge of GMP, FDA, data integrity, and CSV requirements.
- Experience supporting integrations between MES, SAP, LIMS, historians, or other manufacturing systems.
- Strong troubleshooting, root cause analysis, and problem-solving skills in a regulated production environment.
- Proven ability to collaborate effectively with Manufacturing, Quality, Validation, Automation, and IT stakeholders.
Requirements
- Bachelor's degree in Engineering, Computer Science, Information Technology, or a related technical field
- 5+ years of professional experience within pharmaceutical, biotechnology, life sciences, or regulated manufacturing environments
- 3+ years of experience supporting MES platforms, preferably involving PAS-X and electronic batch records
- Hands-on experience configuring, developing, maintaining, or enhancing PAS-X MES solutions
- Demonstrated knowledge of GMP, FDA, data integrity, and CSV requirements
- Experience supporting integrations between MES, SAP, LIMS, historians, or other manufacturing systems
- Strong troubleshooting, root cause analysis, and problem-solving skills in a regulated production environment
- Proven ability to collaborate effectively with Manufacturing, Quality, Validation, Automation, and IT stakeholders
Benefits
- Health, Life & Disability Benefits
- 401(k) with Company Match
- Performance-Based Cash Incentive
- Annual Equity Awards
- Vacation & Personal Days
- Holidays
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.