Electronic Batch Record Specialist
Core
Design, deploy, and continuously improve Electronic Batch Records (EBR) within Manufacturing Execution Systems (MES) to ensure compliant, audit-ready digital execution of biologics manufacturing processes.
Role type
Manufacturing Execution Systems (MES) Specialist / Electronic Batch Record Specialist
Builds
Digital batch records, MES objects, and compliant manufacturing execution workflows for Antibody-Drug Conjugate (ADC) biologics.
Domain
Biologics manufacturing / Digital Manufacturing / GXP
Required skills
GXP environment expertise, MES deployment and configuration, User Requirement Specifications, commissioning and validation, GMP and SOP knowledge, deviation and change control, shopfloor troubleshooting, technical documentation, cross-functional coordination
Preferred skills
Professional technical qualifications, product supply chain concepts, machinery and process performance interactions
Technologies
Manufacturing Execution Systems (MES), digital manufacturing tools
Responsibilities
Drive MES deployment and continuous improvement; Define and maintain User Requirement Specifications; Coordinate stakeholders to configure MES objects; Lead commissioning, testing, and validation of MES objects; Create and maintain SOPs and technical documentation; Provide training and user enablement for MES systems; Manage object lifecycle for new products and process changes; Drive quality management activities including deviation and change control; Deliver real-time shopfloor support; Ensure audit readiness for regulatory inspections.
Seniority
Mid-level, hands-on IC
