Manufacturing Systems Expert
Durham, NC - USA
Job Summary
Band
Level 3Job 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 $85400 and $158600 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 addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.
Minimum Requirements:
Bachelors 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 call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
Data Analytics digital skills General Hse Knowledge gmp knowledge process excellence ResilienceAbout Company
Novartis is a global healthcare company based in Switzerland that provides solutions to the evolving needs of patients worldwide.