Electronic Batch Record Specialist
Core
Design, deploy, and continuously improve Electronic Batch Records (EBR) within a Manufacturing Execution System (MES) to connect digital manufacturing with the shopfloor, ensuring compliant, audit-ready execution for biologics production.
Role type
Manufacturing Execution System (MES) Specialist / Electronic Batch Record Specialist
Builds
Digital batch records, MES objects (equipment, logbooks, interfaces), and compliant manufacturing execution workflows
Domain
Biologics manufacturing (ADC, monoclonal antibodies) / Digital Manufacturing / GXP
Required skills
MES implementation and configuration, User Requirement Specifications (URS) authoring, GMP/GXP compliance, commissioning and validation, deviation and change control, SOP creation, shopfloor troubleshooting, continuous improvement, stakeholder coordination
Preferred skills
Professional technical qualifications, product supply chain concepts, machinery and process performance interactions
Technologies
PAS-X, Syncade, Opcenter, Pomsnet
Responsibilities
Drive MES deployment and continuous improvement; Define and maintain User Requirement Specifications; Coordinate stakeholders to configure MES objects; Lead commissioning, testing, qualification, and validation; Create and maintain training materials and SOPs; Provide real-time shopfloor support and troubleshooting; Ensure audit readiness and support regulatory inspections; Apply GMP, SHE, and SOP standards; Coach and develop team members
Seniority
Mid-level (Career Level C), hands-on IC