PbJob Title: Master Batch Record Designer /b /ppbDepartment: /b Manufacturing / MES Design /ppbr/ppbr/ppbPurpose of the Role /b /ppThe Master Batch Record (MBR) Designer is responsible for consolidating process requirements and translating them into compliant, validated, and optimized electronic Master Batch Records within the Manufacturing Execution System (MES). This role ensures alignment with GMP standards, client's guidelines, and other applicable regulations. /ppbr/ppbKey Responsibilities /b /pullibMBR Design Configuration /b /liliDesign and configure electronic Master Batch Records (MBRs) in the MES system, ensuring alignment with process requirements and compliance standards. /liliProgram and parameterize each stage of the manufacturing process within MES (e.g., PAS-X MES Suite). /lilibLifecycle Management /b /liliCoordinate the lifecycle of MBRs, including creation, updates, and retirement, in accordance with GMP and client's standards. /liliMaintain and update Standard Operating Procedures (SOPs) related to MBR design and management. /lilibData Management /b /liliManage master data related to MBRs and equipment within MES. /liliCreate and maintain MBRs for new SKUs, process variations (PV), and line changes (PVL). /lilibValidation Compliance /b /liliEnsure MBRs are verified and validated according to regulatory and internal quality requirements. /liliSupport internal and external audits related to MBR design and MES configuration. /lilibContinuous Improvement /b /liliParticipate in quality improvement initiatives to optimize MBR design and MES performance. /liliIdentify opportunities and risks in MBR processes and propose actionable solutions. /li /ulpbr/ppbProfile Requirements /b /pullibEducation: /b /lili University degree in Engineering, Computer Science, or a related field. /lilibExperience: /b /lili Minimum of 5 years of experience in MBR design using MES systems (preferably PAS-X MES Suite). /lilibKnowledge Skills: /b /liliStrong understanding of GMP and pharmaceutical manufacturing processes. /liliProficient in MES systems and electronic batch record design. /liliExcellent communication and presentation skills. /liliAbility to collaborate across local and global teams. /liliFluent in English. /li /ul