HCG - MES Engineer

Job Description

We are seeking a talented and experienced MES Engineer with 5+ years of experience in the pharmaceutical industry. The ideal candidate will have a strong background in Manufacturing Execution Systems (MES) and a deep understanding of pharmaceutical manufacturing processes. As an MES Engineer, you will play a crucial role in supporting MES systems, troubleshooting technical issues, and driving continuous improvement initiatives to enhance operational efficiency.

Responsibilities:

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

Requirements

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