Werum PAS-X MES

Job TitleWerum PAS-X SME Subject Matter ExpertTechnical/Functional SkillsWerum PAS-XKey ResponsibilitiesOversee the end-to-end MES service delivery lifecycle, including planning, implementation, operation, and continuous improvement.Develop and implement service delivery strategies and processes aligned with business objectives and regulatory compliance.Monitor and manage key performance indicators (KPIs) to measure service delivery effectiveness and compliance adherence.Ensure adherence to SLAs, SLOs, and regulatory requirements.Manage service requests, incidents, and problems while maintaining compliance.Coordinate with IT infrastructure, quality assurance, and regulatory affairs teams.Build and lead a high-performing MES service delivery team.Provide coaching, mentoring, and development opportunities for team members.Foster a culture of compliance, quality, and continuous improvement within the teamBuild strong relationships with the customers.Understand customer needs and requirements in the context of life sciences regulations.Manage customer expectations and resolve issues promptly while maintaining compliance.Proactively identify and address customer pain points and regulatory challenges.Liaising with various product (operations, validation) experts and subject matter experts to determine the requirements for the new MBRTroubleshoot and defects resolution during validation of Master Batch RecordsStrong Pharmaceutical, Bio Tech, Manufacturing and Shop Floor Order processes knowledge to convert the site requirements into Batch RecordsExperience RequiredDesign and creation of complex MBR for Weighing & Dispensing, Manufacturing and Packaging processesSite specific requirement analysis for each of the above processes and convert them into Batch RecordsValidation of the created MBRs for site deploymentExperience on Werum PAS-X System Administration, GMBRs, PVL, PMBR’s, Equipment Management, Material Flow, Weigh & Dispense, EBR, MBR & Master DataDesigning and developing State Diagrams in MESDetermining updates for Master Data, State Diagrams, Equipment managementExperience on SAP-MES interface, L2 integrations, report developmentKnowledge of ISA95/S88 standards & practical use of these standards in application design, Knowledge of Pharma manufacturing.Good Communication and Analytical skillsHands on Experience in Werum PAS-X Specification, Execution, Compliance & Performance ModuleExperience in Werum PAS-X - Configuration, CustomizationExperience on Werum PAS-X Installation, Upgrade, Development and Configuration.Knowledge of GxP, GAMP, 21 CFR Part 11Roles & ResponsibilitiesWerum PAS-X Service Delivery ManagerOffshore LeadClient LiasoningIT SkillsKnowledge on SQL queries, C-Sharp, Java,User management and system profile creations.Generic Managerial SkillsProven experience in MES implementation and support within the life sciences industry.Deep understanding of MES functionalities and industry best practices.Strong knowledge of relevant regulations (e.g., FDA, EMA, GxP) and compliance requirements.Experience in IT service management frameworks (ITIL) is preferred.Excellent project management and organizational skills.Strong leadership and interpersonal skills.Ability to build and maintain relationships with stakeholders, including regulatory agencies.Strong problem-solving and analytical skills.Excellent communication and presentation skills.