MES PASX Technician (Electronic Batch Record creation)

CIS International LLC; Las Piedras (PR); Hybrid; USD 65,000 - 85,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking an MES Technician to support electronic batch records and manufacturing execution systems using PAS-X. The role involves ensuring compliance with GMP and FDA regulations, collaborating across teams, and providing training on MES usage. Candidates should possess a Bachelor's degree in Engineering or Computer Science, along with relevant industry experience.

Qualifications

• 3+ years of experience in MES PAS-X operations in a pharmaceutical environment.
• Basic understanding of GMP, FDA, and ISO regulations.
• Knowledge of MES validation and documentation.

Responsibilities

• Create EBRs using PAS-X and assist in MES system operations.
• Troubleshoot and resolve day-to-day MES issues.
• Support data entry, validation, and documentation in MES.

Skills

Troubleshooting skills

Effective communication

Teamwork

Education

Bachelor´s degree in Engineering, Computer Science, or related field

Tools

SQL databases

PAS-X

Automation technologies

Job description

Job Summary:

The MES Technician will support the creation, operation, maintenance, and troubleshooting of Electronic Batch Records inManufacturing 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 MESPAS-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