Pharma MES Project Lead

Job Summary Seeking an experienced MES User Project Leader to drive the implementation and optimization of Manufacturing Execution Systems in Singapore site. This critical role sits at the intersection of manufacturing excellence and digital transformation, leading initiatives that enhance operational efficiency, and ensure regulatory compliance As an MES User Project Leader, you will lead the implementation of the MES project and serve as the bridge between business users and technical teams, translating manufacturing needs into system requirements. Responsibilities MES Implementation and Project Leadership Lead end-to-end MES implementation projects from initiation through deployment and post-go-live support Develop comprehensive project plans, timelines, resource allocation, and risk mitigation strategies Coordinate with Digital, Quality, MSAT and operations teams to ensure successful project delivery Manage project scope and schedule while maintaining alignment with business objectives Facilitate project governance meetings and provide regular status updates to leadership User Requirements Gathering and Analysis Conduct detailed business process analysis and workflow mapping for manufacturing operations Collaborate with shop floor users, supervisors, and management to identify pain points and improvement opportunities Translate business requirements into functional specifications for MES configuration Ensure requirements align with GMP regulations, data integrity principles, and industry best practices Stakeholder Management Build and maintain excellent relationships with cross-functional stakeholders including Manufacturing, Quality, Engineering and Digital Facilitate workshops and collaborative sessions to drive consensus and decision-making Serve as the primary point of contact for MES-related inquiries and escalations Present project updates and business cases to senior leadership System Configuration and Testing Oversight Oversee MES system configuration to meet business requirements and regulatory standards Coordinate User Acceptance Testing (UAT) activities and manage anomaly resolutionValidate system functionality against requirements and quality standards Support integration testing with other enterprise systems (ERP, DeltaV, Historian, etc.) Ensure proper documentation of system configurations and validation activities Documentation and Compliance Ensure all project deliverables meet regulatory requirements (21 CFR Part 11, EU Annex 11, data integrity) Maintain comprehensive project documentation including requirements, design specifications, and validation records Support audit readiness and respond to regulatory inspections Implement and maintain document control procedures Requirements Bachelor's degree in Engineering (Chemical, Industrial, Manufacturing, or related field), Computer Science, Information Systems, or related discipline Minimum years of experience in pharmaceutical or regulated manufacturing environments At least 5 years of hands-on experience with MES systems implementation or support Proven track record of successfully leading cross-functional projects from conception to completion Experience with manufacturing operations in GMP-regulated environments Demonstrated experience in requirements gathering, business process analysis, and system implementation Excellent knowledge of MES platforms (e.g., Siemens OpCenter SIMATIC IT, Werum PAS-X, or similar) Understanding of manufacturing processes including batch management, material tracking, production scheduling, and quality management Familiarity with project management methodologies (Agile, Waterfall, Hybrid) Knowledge of system integration concepts and enterprise architecture Understanding of database concepts and reporting tools Knowledge of FDA 21 CFR Part 11, EU Annex 11, and data integrity guidelines (ALCOA+) Familiarity with validation methodologies (IQ/OQ/PQ, CSV) Understanding of Industry 4.0 concepts and digital manufacturing trends Knowledge of ISA-95 standards and manufacturing operations management #J-18808-Ljbffr