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Tier-1 employer, metro location, and a generic Business Analyst title increase competition despite niche LIMS requirement.
Requires regulated GxP lab experience and LIMS/LES expertise, limiting cross-industry transferability.
Explicit 7-11 years and mandatory GxP lab LIMS/validation experience raise shortlisting strictness.
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Lead requirement gathering and translate business needs for QC Lab operations into functional and technical specifications for the Biovia OneLab platform.
Support SDLC development, GMP validation, and regulatory compliance (FDA 21 CFR Part 11, data integrity) in a regulated GxP environment.
Drive documentation standards, mentor contributors, and assist in testing, training, and system configurations related to Lab Execution Systems.
7-11 years experience as Business Analyst/Technical Analyst in regulated GxP pharma lab environment.
Experience with Laboratory Information Systems (LIMS) or Laboratory Execution Systems (LES).
Proficiency with regulatory compliance standards and validation in pharma (FDA 21 CFR Part 11, Computer System Assurance).
Work Experience Required: 7-11 years in relevant pharma/lab IT roles.
Experienced in global, complex digital transformation projects within pharmaceutical lab settings.
Technical ability in light coding, database querying (SQL), and system configurations to support IT delivery.
Strong collaboration and communication skills for cross-functional stakeholder engagement in compliance-driven environments.