The Manufacturing System Expert provides technical expertise in support of all issues linked to electronic batch records (eBRs). The MES Expert supports MES deployment, implementation, and continuous improvement in the Manufacturing Units and provides shop floor routine technical support.
About the RoleYour Responsibilities:
Define User requirement specifications (Voice of customer)
Design and create electronic batch files (EBR) with respect for quality, costs, and deadlines
MBR/BOM/Recipe creation in production IT systems
Participate in the qualification and risk assessment processes
Propose and technically validate the choice of solutions proposed by the IT teams and Automation in collaboration with the Quality team
Participate in the deployment of MES across the manufacturing units, run performance qualification and validation batches (commissioning of the line) with the manufacturing units
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
Ensure the transfer of information to production teams following issues or modifications having a technical, quality, or HSE impact
Responsible for MES/MIS technical knowledge transfer to the shop floor
Ensure the preparation of audits and inspections for related topics
Collaborate with process experts in the context of deviations related to MES/MIS and continuous process improvement
Participate in change management in close collaboration with change champion and P&O partner
Ensure the application of local rules, procedures, and policies
What you'll bring to the role:
Minimum 5 years of experience in GMP manufacturing process support role
Proven experience in MES expert role
University degree in Science is required, Pharmacy or Chemical Engineering, Pharmaceutical Technology, or equivalent job experience
Good scientific and technical (automation) understanding
Deep process understanding
Quality and compliance skills
Team player with strong team spirit
Change management, adaptability, ability to work under pressure
Mastering of automation and computer skills
Good understanding of regulatory requirements across multiple health authorities
Mastering of manufacturing execution systems (MES, SAP, or other as applicable)
Good office software applications
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.#J-18808-Ljbffr