**About the Role**:
**This is an Open Role, Available for Immediate Job Selection.**
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._
**Job Sourcing Statement**:
**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.
Division
Operations
Business Unit
US PHARMA
Location
Mexico
Site
Ciudad de México
Company / Legal Entity
NOV PHA MEX
Functional Area
Technical Operations
Job Type
Full Time
Employment Type
Regular
Shift Work
No
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