MES (PharmaSuite) Support Analyst
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Department Introduction: Our department (Industrial Autonomy & Engineering: IAE) is a delivery organization and is responsible for providing IT services in the industrial and engineering fields. Based on a global standard, we promote high-quality delivery of customer projects and business process improvement, providing IT value to various companies in Japan. Job Description: You will be responsible for the operation and technical support of "PharmaSuite," a next-generation MES (Manufacturing Execution System) that will be introduced at the manufacturing sites of a global pharmaceutical manufacturer.This position allows you to acquire advanced expertise in MES, Electronic Batch Records (EBR), and GxP environments while supporting the advancement of DX in the pharmaceutical industry on the front lines. You will play a crucial role in supporting stable production activities by collaborating with global teams and manufacturing site experts. Main
Responsibilities: Tier 3-level technical support for PharmaSuite System failure investigation and troubleshooting after MES implementation Fit-Gap analysis and promotion of business process standardization with manufacturing departments and business SMEs Design, configuration, and verification of Electronic Batch Records (EBR) EBR construction and operational support in development, staging, and production environments Participation in global conferences and technical support as a local SME Organization of system improvement requirements and coordination with related teams Operational support during Go-Live and Hyper Care periods Progress reporting and issue management to IT managers and stakeholders Position Highlights: Participate in cutting-edge MES projects in the pharmaceutical industry. You can be involved in important projects supporting the manufacturing DX of global pharmaceutical companies. This environment allows you to enhance your expertise in MES, EBR, and smart manufacturing. Global Environment: Opportunities to communicate with overseas teams and participate in international conferences will help you improve your English skills and global capabilities. This position offers opportunities to grow as a specialist in the smart factory field for the pharmaceutical industry.
Requirements Eligibility: Practical experience in MES or Manufacturing IT (approximately 6 years or more) Knowledge of pharmaceutical manufacturing processes Experience in GxP-related document creation and validation Knowledge and experience of Rockwell PharmaSuite or EBR-related systems Ability to participate in meetings and perform tasks in English Bachelor's degree or higher (Engineering, Information Technology, Computer Science, Pharmacy, etc.) or equivalent experience Preferred: Experience in PharmaSuite implementation/migration projects Agile project experience Team lead or sub-leader experience Ability to act autonomously and proactively address challenges