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 systemrelated issues working closely with crossfunctional teams to minimize downtime and ensure uninterrupted manufacturing operations. System Configuration and Customization: Collaborate with endusers 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 crossfunctional 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 endusers 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 Bachelors 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 handson experience in one or more leading MES platforms (e.g. Werum PASX 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.
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.
