Senior MES eMBR Author & Coordination Lead

TechDigital Group; Lithia Springs (GA); Sur place; USD 110 000 - 150 000; Plein temps

Résumé du poste

TechDigital Group is seeking a Senior MES MBR Author & Coordinator to lead end-to-end eMBR execution for GMP manufacturing. You will work with Manufacturing, QA, and IT to ensure accurate, compliant, and production-ready master records during shop-floor execution.

The role requires experience with Client-X eMBRs, ALCOA+ data integrity, validation deliverables, and strong collaboration across multi-disciplinary teams to drive timely approvals and successful campaigns.

Qualifications

• Experience with GMP concepts (ALCOA+ data integrity, electronic signatures, validation, audit trails)
• Strong communication and interpersonal skills for cross-functional collaboration
• Experience in sterile/manufacturing environments with biologics/cell therapy is a plus

Responsabilités

• Author, configure, and maintain Client-X eMBRs/master recipes with steps, equipment phases, material use, data collection, prompts, checks, and signatures
• Translate process descriptions and manufacturing instructions into Client-X implementations
• Build in error-proofing (constraints, logic, dependencies) to reduce deviations and support ALCOA+ data integrity
• Maintain master data elements (materials, BOMs, equipment, parameters, sample points)
• Coordinate cross-functional reviews (Manufacturing, QA, MSAT, Validation, IT) and drive approvals
• Manage master record versioning, traceability, and controlled release with site change control
• Ensure eMBR design/changes meet GMP and data integrity requirements
• Provide on-site support for manufacturing execution and on-the-floor issues
• Support deviation investigations with trace analysis and remediation actions
• Support manufacturing campaigns with floor presence during start-up and cutovers

Connaissances

MBR design

Data integrity knowledge

Strong communication

Outils

PASX (Werum/Koerber) MBR

Description du poste

Must Have's:
1. PASX (Werum / Koerber) MBR 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 MBR 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 eMBR 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.