Description

You will bridge the gap between scientific operations and IT implementation for BioAnalytical workflows. You own the requirements gathering, LIMS configuration, and compliance validation processes.

Responsibilities

• Capture detailed business requirements from scientists, lab managers, and QA to define future-state workflows.
• Support configuration and deployment of LabVantage LIMS and ELN modules, mapping sample and reagent lifecycle processes.
• Design test cases and support User Acceptance Testing (UAT) to ensure GxP compliance and system validation.
• Collaborate with data teams to define data models, KPIs, and reporting dashboards for operational insights.
• Maintain audit-ready documentation aligned with 21 CFR Part 11 and ALCOA+ principles.

Required Skills

• 5+ years as a Business Analyst in BioAnalytical or pharmaceutical laboratory settings.
• Hands-on experience with BioAnalytical workflows: sample handling, assay execution, method validation, and stability studies.
• Strong expertise in LIMS/ELN systems, specifically LabVantage LIMS.
• Proficiency in SQL and data analytics tools for reporting and data modeling.
• Deep understanding of regulatory guidelines including GxP and 21 CFR Part 11.
• Experience documenting reagent lifecycle processes, qualification, and expiry tracking.

Preferred Skills

• Experience with LabVantage modules: LV Analytics, ELN, Stability, Sample Management, or Instrument Management.
• Background in system validation (CSV) activities for regulated environments.

Key Skills

Education

Bachelor's degree