We are seeking a talented and experienced MESEngineer with 5 years of experience in the pharmaceutical industry. Theideal candidate will have a strong background in Manufacturing ExecutionSystems (MES) and a deep understanding of pharmaceutical manufacturingprocesses. As an MES Engineer, you will play a crucial role in supporting MESsystems, troubleshooting technical issues, and driving continuous improvementinitiatives to enhance operational efficiency.

Responsibilities:

• MES Support and Maintenance: Provide technical support for MES systems,ensuring their availability, reliability, and performance. Troubleshoot andresolve any system-related issues, working closely with cross-functional teamsto minimize downtime and ensure uninterrupted manufacturing operations.
• System Configuration and Customization: Collaborate with end-users, IT, and otherstakeholders to configure MES systems according to business requirements.Customize and optimize workflows, user interfaces, and reports to improvesystem usability and align with industry best practices.
• System Integration and Data Management: Collaborate with IT and automation teamsto ensure seamless integration of MES with other manufacturing systems (e.g.,ERP, LIMS). Develop and maintain data interfaces, ensuring accurate and timelyexchange of information between systems.
• Change Control and Validation: Assist in the development and executionof change control processes for MES systems. Ensure that system modifications,upgrades, and enhancements comply with regulatory requirements and establishedvalidation protocols.
• Continuous Improvement: Identify opportunities to optimizemanufacturing processes and enhance system functionality. Collaborate withcross-functional teams to implement process improvements, streamline workflows,and automate manual tasks, aiming for increased efficiency, productivity, anddata integrity.
• User Training and Documentation: Provide training and guidance to end-userson MES system functionalities, workflows, and best practices. Develop usermanuals, standard operating procedures (SOPs), and work instructions to ensureconsistent and compliant system usage.
• Compliance and Regulatory Support: Stay up to date with relevant regulatoryguidelines and industry standards (e.g., FDA, GMP) pertaining to MES systems.Assist in ensuring compliance with these regulations through proper systemconfiguration, data management, and documentation practices.

Requirements

• Bachelor's degree in a relevant field(Engineering, Computer Science, or related discipline). Advanced degrees orcertifications are a plus.
• 5 years of experience working with MESsystems in the pharmaceutical industry.
• Solid understanding of MES concepts,functionalities, and their application in pharmaceutical manufacturingenvironments.
• Strong technical skills in configuring andcustomizing MES systems, preferably with hands-on experience in one or moreleading MES platforms (e.g., Werum PAS-X, Siemens SIMATIC IT, Emerson Syncade).
• Proficiency in system integration and datamanagement, including data mapping, interfaces, and data reconciliation.
• Knowledge of manufacturing processes in thepharmaceutical industry, including batch manufacturing, equipment control,electronic batch records, and quality management.
• Familiarity with change control processesand validation principles within a regulated environment.
• Knowledge of regulatory guidelines andstandards, such as FDA regulations, GMP, and data integrity requirements.