Manufacturing Technical Mes System Specialist

This is an Open Role, Available for Immediate Job Selection.
Novartis is unable to offer relocation support for this role. Please only apply if Mexico City is accessible for you. This role will remotely support international manufacturing locations.
The Manufacturing Execution System (MES) Systems 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 remote United States manufacturing locations.
Key Responsibilities:
• Fluent English 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.
• 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.
• 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.

Essential Requirements:
• Bachelor’s degree required.
• 3 years’ experience in a regulated cGMP environment or other regulatory related industry
• 1 - 3 years Manufacturing Execution Systems
• Fluent English speaking and written communication.
• Strong aseptic manufacturing knowledge background preferred.
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! Learn more here: People and Culture | Novartis.
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: Novartis Talent Pool.