Senior MES MBR Author
- Nityo Infotech
23 Hours Ago
NA
W2, C2C
Lithia Springs-GA
6-10 Years
Required Skills: data integrity, ALCOA+, electronic signatures, validation requirements, audit trails, controlled documents, deviations, CAPA, change control
Job Description
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 PAS-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 PAS-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 PAS-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 PAS-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.
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 PAS-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 PAS-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 PAS-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 PAS-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.
