Job Description 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
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 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 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.
Salary Range
$85,400.00 - $158,600.00
Skills Desired
Data Analytics, Digital Literacy, Health, Safety, and Environment (HSE) PolicySkills Required
- Bachelor's degree in Engineering, Computer Science, Information Technology, or a related technical field
- 5+ years of professional experience in pharmaceutical, biotechnology, life sciences, or regulated manufacturing environments
- 3+ years of experience supporting MES platforms, preferably PAS-X and electronic batch records
- Hands-on experience configuring, developing, maintaining, or enhancing PAS-X MES solutions
- Knowledge of GMP, FDA, data integrity, and CSV requirements
- Experience integrating MES with SAP, LIMS, historians, or other manufacturing systems
- Strong troubleshooting, root cause analysis, and problem-solving skills in a regulated production environment
- Ability to collaborate with Manufacturing, Quality, Validation, Automation, and IT stakeholders
Novartis Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Novartis and has not been reviewed or approved by Novartis.
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Healthcare Strength — Pay and benefits are described as a strong overall package, supported by medical, dental, and vision insurance alongside FSAs/HSAs and disability and life coverage. Mental-health support is reinforced through an employee assistance program with psychological support and a network of mental health first aiders.
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Retirement Support — Retirement support is positioned as a standout element, with an automatic company contribution plus dollar-for-dollar matching in the 401(k). Additional retirement funding is described through an age-based defined contribution program and access to an employee share purchase plan discount.
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Parental & Family Support — Family-related benefits are framed as robust, including a global minimum of paid parental leave for new parents following birth or adoption. Added supports include domestic partner coverage, dependent-care resources, and benefits such as adoption assistance and child/elder care options.
Novartis Insights
What We Do
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
