Manufacturing Systems Expert

Novartis • Durham, NC

4d • Onsite

About The Position

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.

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

Responsibilities

• 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
• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees