MES Master Batch Record (MBR) Designer

Position - MES Master Batch Record (MBR) Designer – PAS-X

Location - Durham NC, hybrid

Job Description -

Needed 9+ yr of experience.

• Review and assess process documentation, batch records, process instructions, and other relevant source materials required to support MES MBR design activities for the applicable site/workstream.
• Perform fit-gap assessment of site-specific requirements against the client's MES Template, applicable global design standards, and approved library elements, and identify justified local adaptations where required.
• Author, configure, update, and maintain MES Master Batch Records within the applicable PAS-X / Global MES environment PAS-X v3.4 in accordance with approved templates, libraries, naming conventions, and design principles.
• Incorporate product- and process-specific data into MBRs, including materials, quantities, process parameters, instructions, calculations, checks, in-process controls, and other required execution elements, based on approved source documentation and client direction.
• Perform required design quality checks, consistency checks, and system integrity checks during authoring, and resolve identified issues prior to formal review and approval.
• Support MBR review cycles, including review coordination, comment resolution, and incorporation of approved feedback from client business, quality, validation, and IT/OT stakeholders.
• Prepare and maintain required design documentation, version history, and traceability records related to MBR development activities, as requested by client.
• Support design verification and deployment readiness activities, including participation in design reviews, dry runs, test preparation, and defect resolution, as applicable within the agreed scope of services.
• Perform the services in accordance with client's quality, compliance, data integrity, documentation, and information security requirements applicable to GxP-regulated MES environments.
• demonstrable experience in PAS-X / MES MBR design within regulated pharmaceutical manufacturing environments and the ability to operate effectively within the client's governance and project delivery framework.