Only W2-Senior MES MBR Author & Coordinator

Job Title: Senior MES MBR Author & Coordinator
Location: Hybrid – 4 days onsite in Lithia Springs, GA
Employment Type: W2
Duration: Contract, with possibility of extension

Must Haves:

1. PAS-X (Werum / Körber) 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.

Job Summary:
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.

Responsibilities:

• 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 onsite, 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.