MES Developer

MES Developer Job DescriptionEssential Duties and Key Responsibilities: Design, configure, and deploy MES solutions (primarily Siemens XFP and Rockwell PharmaSuite)to meet production and compliance requirements. Collaborate with cross‐functional teams, including but, not limited to Manufacturing SME’s,Process Engineering, MS, Quality Assurance, Quality Validation, IT, and the respectivecomputerized system teams related to MES interfaces—to gather and analyze business andprocess requirements. Convert gathered business and process requirements into detailed technical specifications andfunctional designs. Ensure MES solutions are compliant with applicable industry regulations, including cGMP, FDA,ISPE, and GAMP 5 standards. Design, develop, and implement MES process instructions aligned with manufacturingworkflows and business requirements. Set‐up system parameters, master data, and configuration settings. Implement and manage data synchronization processes to maintain consistency and accuracyacross MES and other enterprise systems Develop and support integration workflows between MES and enterprise systems such as JDE,LabWare, OSI PI, and plant automation equipment (e.g., DeltaV). Perform comprehensive integration testing to ensure seamless data exchange between MESand connected systems, resolving any issues discovered during testing. Analyze existing MES code and scripts to understand system logic and processes andtroubleshoot as necessary. Contributes to the configuration, development, troubleshooting, and end‐to‐end testing of MESapplications and system functionalities. Create and maintain detailed documentation, including but not limited to:o Project design traceability documentso Functional and technical design specificationso Commissioning and qualification protocols (IQ/OQ/PQ)o Test cases and validation reportsTechnology Requirements: System Integration Experience: JDE, OSIPI, Labware, and DeltaV MES Platform: Siemens Opcenter Execution Process (formerly known as SIMATIC IT UnifiedArchitecture for Process Industries) a plus, CAMSTAR or any other MES System Database Platforms: Microsoft SQL, Oracle, etc. Project Documentation: Microsoft OfficeEducation and Skills Requirements: Experience in MES Implementation, preferably Siemens Opcenter Minimum 7+ years working experience with some or all the listed “Technologies Used”, asmentioned above. Minimum 7+ years working experience in Pharmaceutical/biotech industries. Experience in FDA regulated industry and familiarity with CFR 21 Part 11, cGMP Technical attitude: ability to learn new systems and information quickly. Demonstration of in‐depth technical capabilities in system supported manufacturing in aregulated environment. Meticulous, conscientious, analytical, focused, self‐starter individual. Excellent communication skills – both verbal and written