Manufacturing Execution Systems Specialist
6 days ago
The Manufacturing Execution Systems (MES) Specialist will oversee and execute automated digitalized business processes, information flow, and documentation for the production lifecycle. This role supports the maintenance, functionality, and change updates of the MES system to manufacture biopharmaceutical products.
Key Responsibilities:- Skilled in Master Batch Record (MBR) creation and maintenance using MES.
- Update Manufacturing SOPs as required.
- Own and support Change Control tasks, Quality Events, and CAPAs related to MES updates.
- Support all aspects of the MES system, including paperless manufacturing instructions, paperless in-process control, process sequencing, and electronic go/no-go decisions.
- Interface with SAP System to issue materials to Master Batch Records (MBR) that are acceptable and released.
- Coordinate the review and revisions of procedures, R&D documentation, and FDA regulations for inclusion in Production instructions and Quality Control manuals.
- Communicate with the broader MES global team to ensure alignment with the Global format and structure.
- Minimum 3 years' experience in a regulated cGMP environment or other regulatory-related industry.
- 1-3 years Manufacturing Execution Systems Experience required.
- Strong aseptic manufacturing knowledge background preferred.
- Skilled in Master Batch Record Creation and Maintenance for both Production using MES.
- Must possess full fluency in MS Office (Word, Outlook, PowerPoint, MES, ERP, database management) and be an excellent communicator.
- Must be service-minded, flexible, and possess strong interpersonal skills.
The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds, and perspectives.
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Manufacturing Execution Systems Specialist
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Morris, United States Advanced Accelerator Applications (Italy) - S... Full timeAbout the RoleThe Manufacturing Execution Systems (MES) Specialist will oversee and execute automated digitalized business processes, information flow, and documentation for the production lifecycle. This role supports the maintenance, functionality, and change updates of the MES system to manufacture biopharmaceutical products.Key Responsibilities:Skilled...
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Manufacturing Execution Systems Specialist
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Morris, United States Novartis Group Companies Full timeJob DescriptionThe Novartis Group of Companies is seeking a skilled Manufacturing Execution Systems Specialist to provide oversight and execution for automated digitalized business processes, information flow, and documentation for the production lifecycle.Key Responsibilities:Skilled in Master Batch Record (MBR) creation and maintenance using MES...
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