Senior MES eMBR Author & Coordination Lead

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.