Summary
About the Role
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:
- 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.
Novartis Compensation and Benefit Summary:
The salary for this position is expected to range between $85,400 and $158,600 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 benefits. In 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, 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.
