Senior MES MBR Author Job Lithia Springs area,Georgia USA,Pharmaceutical

Must Have's:

1. PASX (Werum / Koerber) M Design and Operational Support

2. Life Sciences industry understanding of GMP concepts: data integrity (ALCOA+), electronic signatures, validation requirements, audit trails, controlled documents, deviations/CAPA, and change control

3. Strong Communication and Interpersonal skills to collaborate with diverse stakeholders and drive decisions

Additional Information:

Experience with sterile manufacturing, biologics, cell therapy, or fill-finish operations.
Exposure to interfaces/integration concepts (ERP/LIMS/SCADA), ISA-88/ISA-95, and master data governance.
Experience supporting or authoring validation deliverables (URS/FS/DS, IQ/OQ/PQ) for MES changes.

The Senior MES M Author & Coordinator is responsible for authoring, reviewing, and coordinating end-to-end execution of electronic Master Batch Records (eMBRs) in Client-X for GMP manufacturing. This role partners closely with Manufacturing, Process Engineering, Quality, Validation/CSV, and IT/MES to ensure batch records are accurate, compliant, production-ready, and supported during shop-floor execution

Author, configure, and maintain Client-X eMBRs/master recipes, including process steps, equipment phases, material consumption, data collection, prompts, checks, and electronic signatures.
Translate process descriptions, and manufacturing instructions into robust, right-first-time Client-X implementations.
Build in error-proofing (constraints, limits, conditional logic, dependencies) to reduce deviations and support ALCOA+ data integrity.
Maintain master data elements tied to records (materials, BOM/consumables usage, equipment/units, process parameters, sample points), as required for record execution.
Coordinate cross-functional review cycles (Manufacturing, QA, MSAT, Validation, Automation/IT) and drive to timely approvals.
Manage master record versioning, traceability, and controlled release in alignment with site change control and document management practices.
Ensure eM design and changes meet GMP and site data integrity requirements
Provide on-site, hands-on support for manufacturing execution, including End User training and resolving issues related to Client-X master records (runtime errors, missing master data, step logic issues, signature/role issues).
Support deviation investigations by providing execution trace analysis (where appropriate), master record logic review, and corrective actions to prevent recurrence.
Support planned/critical manufacturing campaigns, including floor presence during start-up, recipe cutovers, and high-risk steps.

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