Overview
Job Title: Business Analyst/Label Designer
Essential Duties and Job Functions:
Responsibilities
Label Design & Development
Design, develop, configure, and optimize labels using Bartender, including advanced templates, dynamic data handling, automation, and printing logic.
Utilize Visual Basic scripting to support conditional logic, formatting, and integration with upstream systems.
Implement standardized label formats across systems and sites to support harmonization and reduce deviations.
Label Lifecycle Management
Drive the full label lifecycle: requirement gathering, design, configuration, testing, validation, production deployment, and support.
Troubleshoot label-related issues across interconnected systems (e.g., MES, Robar, ERP/EBS, Bartender).
Maintain documentation, SOP updates, and knowledge transfer materials.
System & Process Integration
Collaborate with Supply Chain, Regulatory, Quality, Manufacturing, and IT teams to ensure alignment of label workflows with end‑to‑end business processes.
Participate in cross‑functional workshops to define future‑state process flows, roles, responsibilities, and support models.
Ensure solutions comply with cGMP, data integrity requirements, and regulatory standards.
Testing, Validation & Compliance
Develop and execute test plans for label functionality, integrations, and printing performance.
Support validation deliverables and change control processes for regulated systems.
Ensure accuracy, security, and compliance throughout the label lifecycle.
Provide hands-on support during transitions, system upgrades, and site enablement projects.
Assist with troubleshooting high‑priority incidents and participating in cross-team triage.
Identify opportunities to improve labeling processes, tooling, and documentation.
Required Qualifications
Expert-level proficiency with Bartender, including design, automation, and server components.
Strong Visual Basic / VBScript skills applied to label automation and dynamic behavior.
Strong troubleshooting skills in complex labeling ecosystems involving MES, ERP, and printing hardware.
Experience in biotech, pharma, or cell therapy supply chain, with familiarity in materials management, batch/lot control, serialization, and regulated operations.
Ability to collaborate with global cross-functional teams and translate requirements into technical label specifications.
Experience supporting systems and processes within a GMP-regulated environment.
Highly Desirable Qualifications
Experience implementing or supporting laboratory instruments in QC labs or research environments (e.g., , label printers, scanners, nucleocounters, cytometry instruments, and similar).
Experience working in IT site support, particularly in environments managing lab, manufacturing, or supply chain systems.
Experience working with Robar labeling software (configuration, troubleshooting, integration).
Experience with EBS (Oracle E‑Business Suite) for label data sourcing or workflow integration.
Preferred Qualifications
Prior involvement in labeling system standardization, migration, or transformation initiatives.
Familiarity with validation documentation (URS, FRS, IQ/OQ/PQ).
Experience supporting enterprise label architecture involving MES (e.g., PAS-X), ERP, or middleware integrations.
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Essential Duties and Job Functions:
Responsibilities
Label Design & Development
Design, develop, configure, and optimize labels using Bartender, including advanced templates, dynamic data handling, automation, and printing logic.
Utilize Visual Basic scripting to support conditional logic, formatting, and integration with upstream systems.
Implement standardized label formats across systems and sites to support harmonization and reduce deviations.
Label Lifecycle Management
Drive the full label lifecycle: requirement gathering, design, configuration, testing, validation, production deployment, and support.
Troubleshoot label-related issues across interconnected systems (e.g., MES, Robar, ERP/EBS, Bartender).
Maintain documentation, SOP updates, and knowledge transfer materials.
System & Process Integration
Collaborate with Supply Chain, Regulatory, Quality, Manufacturing, and IT teams to ensure alignment of label workflows with end‑to‑end business processes.
Participate in cross‑functional workshops to define future‑state process flows, roles, responsibilities, and support models.
Ensure solutions comply with cGMP, data integrity requirements, and regulatory standards.
Testing, Validation & Compliance
Develop and execute test plans for label functionality, integrations, and printing performance.
Support validation deliverables and change control processes for regulated systems.
Ensure accuracy, security, and compliance throughout the label lifecycle.
Provide hands-on support during transitions, system upgrades, and site enablement projects.
Assist with troubleshooting high‑priority incidents and participating in cross-team triage.
Identify opportunities to improve labeling processes, tooling, and documentation.
Required Qualifications
Expert-level proficiency with Bartender, including design, automation, and server components.
Strong Visual Basic / VBScript skills applied to label automation and dynamic behavior.
Strong troubleshooting skills in complex labeling ecosystems involving MES, ERP, and printing hardware.
Experience in biotech, pharma, or cell therapy supply chain, with familiarity in materials management, batch/lot control, serialization, and regulated operations.
Ability to collaborate with global cross-functional teams and translate requirements into technical label specifications.
Experience supporting systems and processes within a GMP-regulated environment.
Highly Desirable Qualifications
Experience implementing or supporting laboratory instruments in QC labs or research environments (e.g., , label printers, scanners, nucleocounters, cytometry instruments, and similar).
Experience working in IT site support, particularly in environments managing lab, manufacturing, or supply chain systems.
Experience working with Robar labeling software (configuration, troubleshooting, integration).
Experience with EBS (Oracle E‑Business Suite) for label data sourcing or workflow integration.
Preferred Qualifications
Prior involvement in labeling system standardization, migration, or transformation initiatives.
Familiarity with validation documentation (URS, FRS, IQ/OQ/PQ).
Experience supporting enterprise label architecture involving MES (e.g., PAS-X), ERP, or middleware integrations.
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