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