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MES Master Batch Record (MBR) Designer
Career Insights for Curriculum and Instructional Designer / Developer
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Based on North Carolina data
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What they do
A Curriculum and Instructional Designer or Developer designs and develops instructional materials and methods for teachers. Analyzes what is needed for students, identifies learning objectives, and designs the content and format of instructional material and delivery. Uses instructional design to create instructional materials, which may include text, electronic and visual material. Works for a school or college or for an education, software or publishing company.
$75,457 / year median in North Carolina
-5% projected decline
Job Description
MES Master Batch Record (MBR) Designer at Amaze Systems MES Master Batch Record (MBR) Designer at Amaze Systems in Raleigh, North Carolina Posted in 1 day ago.
Type:
full-time 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.