Pharma MES Project Lead (Digital System/ Manufacturing/ Contract)

12-Months Contract Location: Tuas Salary up to $9,500 depending on experience Industry : Pharmaceutical Job SummarySeeking 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 complianceAs 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 LeadershipLead end-to-end MES implementation projects from initiation through deployment and post-go-live supportDevelop comprehensive project plans, timelines, resource allocation, and risk mitigation strategiesCoordinate with Digital, Quality, MSAT and operations teams to ensure successful project deliveryManage project scope and schedule while maintaining alignment with business objectivesFacilitate project governance meetings and provide regular status updates to leadershipUser Requirements Gathering and AnalysisConduct detailed business process analysis and workflow mapping for manufacturing operationsCollaborate with shop floor users, supervisors, and management to identify pain points and improvement opportunitiesTranslate business requirements into functional specifications for MES configurationEnsure requirements align with GMP regulations, data integrity principles, and industry best practicesStakeholder ManagementBuild and maintain excellent relationships with cross-functional stakeholders including Manufacturing, Quality, Engineering and DigitalFacilitate workshops and collaborative sessions to drive consensus and decision-makingServe as the primary point of contact for MES-related inquiries and escalationsPresent project updates and business cases to senior leadershipSystem Configuration and Testing OversightOversee MES system configuration to meet business requirements and regulatory standardsCoordinate User Acceptance Testing (UAT) activities and manage anomaly resolutionValidate system functionality against requirements and quality standardsSupport integration testing with other enterprise systems (ERP, DeltaV, Historian, etc.)Ensure proper documentation of system configurations and validation activitiesDocumentation and ComplianceEnsure 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 recordsSupport audit readiness and respond to regulatory inspectionsImplement and maintain document control proceduresRequirements:Bachelor's degree in Engineering (Chemical, Industrial, Manufacturing, or related field), Computer Science, Information Systems, or related disciplineMinimum 8 years of experience in pharmaceutical or regulated manufacturing environmentsAt least 5 years of hands-on experience with MES systems implementation or supportProven track record of successfully leading cross-functional projects from conception to completionExperience with manufacturing operations in GMP-regulated environmentsDemonstrated experience in requirements gathering, business process analysis, and system implementationExcellent 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 managementFamiliarity with project management methodologies (Agile, Waterfall, Hybrid)Knowledge of system integration concepts and enterprise architectureUnderstanding of database concepts and reporting toolsKnowledge 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 trendsKnowledge of ISA-95 standards and manufacturing operations managementLim Pey Chyi - Apple.lim@manpower.com.sg Recruitment Consultant (R2090579) Manpower Staffing Services (S) Pte Ltd EA Licence: 02C3423Desired Skills and ExperienceBachelor's degree in Engineering (Chemical, Industrial, Manufacturing, or related field), Computer Science, Information Systems, or related disciplineMinimum 8 years of experience in pharmaceutical or regulated manufacturing environmentsAt least 5 years of hands-on experience with MES systems implementation or supportProven track record of successfully leading cross-functional projects from conception to completionExperience with manufacturing operations in GMP-regulated environmentsDemonstrated experience in requirements gathering, business process analysis, and system implementationExcellent 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 managementFamiliarity with project management methodologies (Agile, Waterfall, Hybrid)Knowledge of system integration concepts and enterprise architectureUnderstanding of database concepts and reporting toolsKnowledge 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 trendsKnowledge of ISA-95 standards and manufacturing operations managementApple, Pey Chyi Lim EA License No.: 02C3423 Personnel Registration No.: R2090579Please note that your response to this advertisement and communications with us pursuant to this advertisement will constitute informed consent to the collection, use and/or disclosure of personal data by ManpowerGroup Singapore for the purpose of carrying out its business, in compliance with the relevant provisions of the Personal Data Protection Act 2012. 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