Description

Essential Duties and Job Functions: 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.

Support & Continuous Improvement

• 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.