Job Specifications
12 month contract (extension possible)
Office in Santa Monica CA or El Segundo CA
Large client in biotechnology industry
Job description:
The Company 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. This role requires strong collaboration with IT, Supply Chain, Quality, Manufacturing, and R&D or QC Lab teams to ensure compliant, reliable, and scalable labeling solutions.
The candidate will work with the Company's commercial and clinical supply chain organizations, regulatory affairs, manufacturing and quality stakeholders to support requirements gathering, prototyping, and label design. The candidate will also work with cross functional IT teams on the implementation, testing, deployment, and support of labels. The candidate must be experienced working in GxP environment.
Requirements:
The candidate must have strong collaboration and clear communication skills with ability to present technical concepts to non-technical audiences. The candidate must be comfortable to work with ambiguity, engage and align cross-functional stakeholders and delivery partners. The individual should have experience leading workshops and meetings, bringing people together, and ensuring structured process-driven approach to projects and support. The candidate will be a key point of contact for labeling ensuring projects and dependencies are tracked, risks escalated and mitigation strategies proposed in a timely manner,
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).
• Experi