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MES PASX Technician (Electronic Batch Record creation)

Las Piedras, PR

Job Summary:

The MES Technician will support the creation, operation, maintenance, and troubleshooting of Electronic Batch Records in Manufacturing Execution Systems (MES) using PAS-X within a pharmaceutical manufacturing environment. This role ensures the smooth creation and execution of electronic batch records (EBR) and MES-related activities while maintaining compliance with industry regulations.

Key Responsibilities:

  • Creation of EBRs using PAS-X.
  • Assist in the monitoring and operation of MES systems to ensure seamless manufacturing processes.
  • Make changes, Troubleshoot and resolve day-to-day MES issues, escalating complex problems as needed.
  • Support data entry, validation, and documentation within the MES platform.
  • Assist in system upgrades, maintenance, and integration with ERP, SCADA, and LIMS.
  • Ensure compliance with GMP, FDA, and industry regulations in MES operations.
  • Conduct routine audits and performance checks to maintain system efficiency.
  • Collaborate with cross-functional teams, including manufacturing, quality, and IT, to optimize MES functionality.
  • Provide basic training and support to end-users on MES system usage.
  • Support other related assigned duties.

Qualifications & Experience:

  • Bachelor´s degree in Engineering, Computer Science, or a related field.
  • 3+ years of experience in MES PAS-X operations within a pharmaceutical or regulated manufacturing environment.
  • Proven experience in MES PAS-X system.
  • Basic understanding of GMP, FDA, and ISO regulations related to MES and manufacturing processes.
  • Strong troubleshooting skills and ability to work under supervision.
  • Effective communication and teamwork skills to support manufacturing operations.

Preferred Skills:

  • Experience with SQL databases and automation technologies.
  • Knowledge of MES validation and documentation.
  • Preferred knowledge / experience with PAS-X.
  • Familiarity with data integrity and cybersecurity best practices in manufacturing systems.
Work Methodology:
  • Professional services contract
  • 1 year of first contract assignment
  • Administrative shift - Monday to Friday 8am to 5pm
  • Hybrid work may be allowed

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