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Senior PAS-X MES MBR Author / MES Business Analyst
ICONMA, LLC
🇺🇸 United States
Hybrid
Senior
1 month ago
- GMP
- CAPA
- ERP
- SCADA
1 month ago
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Responsibilities:
- 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.
Requirements:
- PASX (Werum / Koerber) MBR Design and Operational Support
- Life Sciences industry understanding of GMP concepts: data integrity (ALCOA+), electronic signatures, validation requirements, audit trails, controlled documents, deviations/CAPA, and change control
- Strong Communication and Interpersonal skills to collaborate with diverse stakeholders and drive decisions
- 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.
- Years of Experience:Â Â 12.00 Years of Experience
Why Should You Apply?
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
Senior PAS-X MES MBR Author / MES Business Analyst · ICONMA, LLC