ATS Company:
PA Solutions
Requisition ID:
16464
Location:
Cork, Munster, IE
Date:
Feb 6, 2026
MES Engineer (m/f/d)
Job Description
We are seeking a highly skilled MES (Manufacturing Execution System) Engineer to join our team. The ideal candidate will have strong experience in pharmaceutical manufacturing environments and a deep understanding of GxP compliance. This role involves designing, implementing, and supporting MES solutions to optimize production processes, ensure regulatory compliance, and enhance operational efficiency.
Key Responsibilities:
- Design and Configure MES Solutions: Develop and implement MES functionalities to support batch execution, electronic batch records (EBR), and production workflows.
- System Integration: Collaborate with automation, ERP, and IT teams to integrate MES with other systems (e.g., SAP, LIMS, SCADA).
- Compliance & Validation: Ensure MES systems comply with GxP, FDA 21 CFR Part 11, and other regulatory requirements. Prepare and execute validation protocols (IQ/OQ/PQ).
- Troubleshooting & Support: Provide technical support for MES applications, resolve issues, and maintain system reliability.
- Continuous Improvement: Identify opportunities to enhance MES performance and streamline manufacturing processes.
- Documentation: Maintain accurate system documentation, SOPs, and change control records.
Additional Information
- Education: Bachelor’s degree in Engineering, Computer Science, or related field.
- Experience:
- Minimum 3–5 years working with MES systems (e.g., Koerber PAS-X, Rockwell Syncade, or similar).
- Must have Koerber PAS-X experience
- Knowledge of Rockwell Pharmasuite, siemens Opcenter & Emerson Syncade is an advantage
- Strong background in pharmaceutical manufacturing and GxP compliance.
- Experience with system validation and regulatory audits.
- Technical Skills:
- Knowledge of SQL, scripting, and system configuration.
- Familiarity with integration to ERP and automation systems.
Preferred:
- Experience with electronic batch records (EBR) implementation.
- Understanding of ISA-95 and ISA-88 standards.
- Previous involvement in MES deployment projects in regulated environments.