395374BR
May 30, 2024
Mexico
About the Role
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.
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.
Diversity & Inclusion / EEO
We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
- Novartis: e-mail [email protected] or call +1 (877)395-2339
- Sandoz: e-mail [email protected] or call: +1-609-422-4098
Job Sourcing Statement
You are applying to be part of the Novartis Talent Pool. We are not currently recruiting for this role but we are building a pipeline for future opportunities. If you would like to be considered for a similar position in future, then please submit your CV.
Role Requirements
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.
Benefits and rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
• 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.
Benefits and rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Operations
US PHARMA
Mexico
Ciudad de México
NOV PHA MEX
Technical Operations
Full Time
Regular
No
