Manufacturing Technical System Specialist

hace 1 mes


Ciudad de México, Ciudad de México Novartis A tiempo completo
About the Role

This is a highly sought-after position for an experienced Manufacturing Execution Systems (MES) specialist. The role requires providing oversight and execution of automated digitalized business processes, information flow, and documentation for the production lifecycle in remote United States manufacturing locations.

Key Responsibilities:

  • Fluent English oral and written communicator with strong technical writing and proofreading skills to handle multiple conflicting tasks in a fast-paced environment.
  • Skilled in Master Batch Record (MBR) creation and maintenance using MES systems.
  • Update Manufacturing Standard Operating Procedures (SOPs) as required and own Change Control tasks, Quality Events, and Corrective Action Preventative Actions (CAPAs) related to MES updates.
  • Support all aspects of the MES system, including paperless manufacturing instructions, process sequencing, electronic go/no-go decisions, and interface with SAP System to issue materials to MBRs.
  • Coordinate 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 Global format and structure.
  • Responsible for ensuring compliance with Federal, State, and local regulations and adherence to company policies and procedures relating to Good Manufacturing Practices (GMPs), Health, Safety & Environmental standards.
Requirements
  • Bachelor's degree required.
  • 3 years' experience in a regulated cGMP environment or other regulatory-related industry.
  • 1-3 years of experience with Manufacturing Execution Systems.
  • Fluent English speaking and written communication skills.
  • Aseptic manufacturing knowledge background preferred.
Work Environment

The ideal candidate will be based in Mexico and work closely with the US PHARMA team. This full-time position offers regular working hours and no shift work requirements.

Estimated Salary Range

The estimated salary range for this position is $90,000 - $120,000 per annum, depending on qualifications and experience.



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