As a quality and compliance expert, you will be responsible for ensuring that GxP systems and processes adhere to the applicable regulatory requirements throughout the entire system lifecycle. Therefore, you stay up to date about evolving regulations from authorities such as the EMA and FDA and industry standards like GAMP and ISO. Depending on your role and expertise, you may be asked to provide Quality & Compliance support during audits and inspections, or to join a Sopra Steria validation service team.
We are seeking a highly motivated MES (Manufacturing Execution System) Engineer to join our team. As an MES Engineer, you will be responsible for implementing, maintaining, and optimizing our MES to ensure efficient production processes. You will play a key role in configuring the system, providing support to users, and ensuring compliance with industry regulations. Additionally, you will drive process improvements and play a crucial part in system validation.
- Implementation and Configuration:
- Install, configure, and customize MES software to meet production needs.
- Collaborate with cross-functional teams to integrate MES with other systems (ERP, PLC, SCADA, etc.).
- System Maintenance and Administration:
- Perform system maintenance, troubleshooting, and updates to ensure optimal performance.
- Manage user accounts, permissions, and ensure data integrity and security within the MES.
- Validation and Compliance:
- Develop and execute validation plans and protocols to ensure compliance with industry standards and regulatory requirements (e.g., GAMP, FDA).
- Maintain detailed validation documentation, test results, and reports.
- Process Optimization:
- Analyze production processes and workflows, identify inefficiencies, and implement improvements through MES automation.
- Work with production teams to implement best practices and optimize system use.
- Support and Troubleshooting:
- Provide technical support for MES users and resolve any system-related issues.
- Conduct user training and ensure adherence to best practices for system use.
- Project Management: