Band

Level 3

Job Description Summary

The MES Expert will provide technical expertise in support of all issues linked to electronic batch records (eBRs). MES Expert supporting MES deployment, implementation and continuous improvement in the Manufacturing Units and providing shop floor routine technical support.

Location: Morrisville
Onsite
1st shift role (Monday through Friday)

Job Description

Major Accountabilities:

• Responsible for the manufacturing documentation update following the implementation of electronic batch files

• Provide training for MES users in partnership with the training team

• Ensure follow-up and processing of deviations and Change Control in compliance with deadlines and applicable regulations

• Real time shop floor troubleshooting with the implementation of appropriate immediate corrective actions

​Expertise / Compliance

• Subject matter expert for MES / SAP / Historian type of production IT systems

• Support deviation and complaint investigations process using investigation tools and methodology

• Develop on-site expertise (MBR design, PAS-X, OSI-PI, interface with SAP and Trackwise)

• Master PAS X and OSI PI systems

• SPOC for major trouble shooting, CAPA execution, change controls management and follow-up for production IT systems

• Prepare, support and follow-up of Health authority and internal inspections

Continuous improvement

• Continually seek to improve the efficiency of its work and simplify processes

• Contribute to continuous improvement by making proposals and participating in the implementation of tangible and effective actions.

The salary for this position is expected to range between $81,200 and $150,800 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.

Minimum Requirements:

• Bachelor's Degree in Science, Pharmacy, Chemical Engineering or Pharmaceutical Technology or equivalent job experience.

• 5+ years of relevant experience in GMP manufacturing process support role.

• Proven experience in MES expert role

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, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

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 in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com 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.

https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

Salary Range

$81,200.00 - $150,800.00

Skills Desired

Data Analytics, digital skills, General Hse Knowledge , gmp knowledge, process excellence, Resilience