Advanced Accelerator Applications (Italy) - S...
Mfg Technical MES System Specialist
Advanced Accelerator Applications (Italy) - S..., Morris Plains, New Jersey, us, 07950
The Manufacturing Execution Systems (MES) Specialist will provide oversight and execution for the 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 for the Morris Plains, Cell Processing Operations.About the Role
Key Responsibilities:Skilled in Master Batch Record (MBR) creation and maintenance using MES (Manufacturing Execution Systems).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 - paperless manufacturing instructions, paperless in process control, enforces process sequencing and electronic go/no go decisions, process validation ranges, formulas to ensure the final yield is within acceptable percentages, interface with SAP System to issue materials to Master Batch Records (MBR) that are acceptable & 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 broader MES global team to ensure alignment with the Global format and structure.Exceptional oral and written communicator who is proactive, responsive, and able to work independently with all levels of the organization. Ability to handle multiple conflicting tasks in a fast-paced environment is a must. Very high attention to detail is critical, including strong technical writing and proofreading skills.Responsible for ensuring compliance with Federal, State and local regulations and adherence to all company policies and procedures relating to GMP’s, Health, Safety & Environmental Protection.Minimum Requirements:
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 (Manufacturing Execution Systems).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. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.Accessibility & 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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or 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.Division:
OperationsBusiness Unit:
Innovative MedicinesLocation:
USASite:
Morris PlainsCompany / Legal Entity:
U014 (FCRS = US014) Novartis Pharmaceuticals Corporation
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Key Responsibilities:Skilled in Master Batch Record (MBR) creation and maintenance using MES (Manufacturing Execution Systems).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 - paperless manufacturing instructions, paperless in process control, enforces process sequencing and electronic go/no go decisions, process validation ranges, formulas to ensure the final yield is within acceptable percentages, interface with SAP System to issue materials to Master Batch Records (MBR) that are acceptable & 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 broader MES global team to ensure alignment with the Global format and structure.Exceptional oral and written communicator who is proactive, responsive, and able to work independently with all levels of the organization. Ability to handle multiple conflicting tasks in a fast-paced environment is a must. Very high attention to detail is critical, including strong technical writing and proofreading skills.Responsible for ensuring compliance with Federal, State and local regulations and adherence to all company policies and procedures relating to GMP’s, Health, Safety & Environmental Protection.Minimum Requirements:
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 (Manufacturing Execution Systems).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. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.Accessibility & 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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or 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.Division:
OperationsBusiness Unit:
Innovative MedicinesLocation:
USASite:
Morris PlainsCompany / Legal Entity:
U014 (FCRS = US014) Novartis Pharmaceuticals Corporation
#J-18808-Ljbffr