MES Engineer

PharmEng Technology is seeking an experienced MES Application Engineer for a project in Houston Texas to help drive our solution-based business model and take our designs to the next level. The MES Application Engineer is responsible for supporting activities such as requirements gathering, definition, and application/test/implementation of Manufacturing Execution System (MES) client projects; primarily, but not limited to, the pharmaceutical/biotech industries.

Job Responsibilities:

• Responsible for execution of protocols for testing and validating electronic batch records.
• Responsible for testing of MES systems project, which includes infrastructure setup, software installation, recipe development, and System Acceptance Testing (SAT) with users.
• Working with MES leads, system users and process owners to develop, revise and maintain MES recipes.
• Responsible for creating and maintaining electronic logbooks and electronic batch records.
• Responsible for creating and maintaining electronic batch records and configuring production recipes using object libraries.
• The potential resource should be capable of driving the testing and deployment of Opcenter software solutions, ensuring sufficient automated testing to maintain solution quality.
• The potential resource must have experience with Electronic Batch Record System Modeling specifically in the Siemens Opcenter platform.
• Responsible for assisting in designing and deployment of MES systems to replace paper-based or manual systems including batch records, weigh & dispense, warehouse management and material tracking in a pharmaceutical or medical device environment.
• Actively participate in fit-gap analysis of customer requirements vs. MES system functionality.
• Provide technical input to help troubleshoot issues during MES usage and support end-users in MES navigation, EBR execution and general system utilization to ensure users become self-sufficient.
• Practical hands-on experience with Siemens Opcenter is required.
• The potential resource should have experience in gathering requirements and translating them into a product vision, demonstrating expertise in development and engineering.
• Experience in application development, testing, and support based on the Software Development Life Cycle (SDLC) methodology is necessary. Demonstrated understanding of key pharmaceutical niche processes, Pharma GxP regulations, and ISA-88/ISA-95 standards is important in this role.

Job Requirements:

• Bachelor’s Degree in Engineering/Computer Science/Integrated Manufacturing disciplines or equivalent experience.
• Firm understanding of cGMP validation requirements/guidelines and current industry practice.
• More than 4 years of working experience with JAVA, Oracle, C, C++and SQL.
• More than 4 years of working experience with SAP and ERP.
• More than 4 years of working experience with Werum PAS-X, Syncade, and Aspen Tech.