CSI Companies · 23 hours ago
Business Intelligence Lead
CSI Companies is seeking an experienced BI Lead – Data Reporting & Analytics to support a Life Sciences organization operating within a clinical manufacturing and GMP-regulated environment. This role involves leading reporting and analytics initiatives, designing and maintaining BI dashboards, and ensuring compliance with regulatory standards.
Responsibilities
Serve as the BI lead for reporting and analytics initiatives supporting clinical manufacturing operations within a GMP-regulated environment
Design, develop, and maintain BI dashboards, reports, and data models using data sourced from clinical manufacturing systems
Work directly with clinical manufacturing, quality, and operations stakeholders to translate functional requirements into scalable reporting solutions
Integrate and analyze data from manufacturing and laboratory systems, including:
PI Historian
LIMS (Laboratory Information Management Systems)
MES (Manufacturing Execution Systems)
Real-time manufacturing data sources
Ensure all analytics and reporting solutions comply with GMP, data integrity, and regulatory standards
Lead data validation, reconciliation, and quality checks to ensure accuracy, traceability, and audit readiness
Partner with data engineers and IT teams to guide data pipelines, transformations, and reporting architecture specific to clinical manufacturing data
Support ongoing enhancements, troubleshooting, and optimization of BI solutions as manufacturing processes evolve
Qualification
Required
5–8 years of combined functional and technical experience in BI, reporting, and analytics within a Life Sciences clinical manufacturing environment
Proven BI leadership experience within a Life Sciences clinical manufacturing environment
Direct, hands-on experience working with GMP-regulated data from clinical manufacturing systems
Strong functional understanding of clinical manufacturing workflows, quality processes, and regulatory requirements
Demonstrated experience building analytics using data from PI Historian, LIMS, MES, and real-time manufacturing systems
Strong SQL and data modeling skills, with experience supporting enterprise BI tools (e.g., Power BI, Tableau, or similar)
Ability to bridge the gap between technical teams and business stakeholders, especially within manufacturing and quality
Experience ensuring data integrity, validation, and compliance in regulated environments
Excellent communication skills and the ability to lead discussions with cross-functional teams
Preferred
Experience supporting clinical trial manufacturing or early-phase manufacturing operations
Familiarity with FDA, EMA, or other regulatory expectations related to data reporting
Prior consulting experience in Life Sciences or pharmaceutical manufacturing
Experience working in hybrid/on-site manufacturing environments
Company
CSI Companies
Headquartered in Jacksonville, FL, CSI Companies partners with organizations nationwide to deliver solutions-focused workforce services.
Funding
Current Stage
Growth StageRecent News
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