Senior BSA (Label Design & Implementation)

Position Title: Senior BSA (Label Design & Implementation)

Work Location: El Segundo or Santa Monica, California (Onsite)

Assignment Duration: 12 months (extensions possible)

Position Summary:

The Position Our organization requires the services of a Senior BSA Label Design & Implementation Contractor with deep expertise in Bartender label design software and Visual Basic (VB) scripting. The ideal candidate will support end-to-end label lifecycle activities-including design, configuration, testing, validation, and deployment-within a GxP-regulated biopharma, biotech, or cell therapy environment.

Key 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.

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.

Qualification & Experience:

* 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.

* 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.

* 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.