Sr Validation Specialist (Watson/LIMS)

Thermo Fisher Scientific

Senior Validation Specialist role supporting LIMS products and computer system validation at Thermo Fisher Scientific. Responsibilities include implementing and configuring Watson and related LIMS platforms, developing validation documentation, executing testing protocols, and ensuring GxP/GLP compliance in regulated laboratory environments.

Responsibilities

Implement, configure, maintain, and troubleshoot Thermo Scientific LIMS products and modules
Develop and execute validation documentation including requirements, protocols, test scripts, and reports
Perform functional, regression, integration, and user-acceptance testing with detailed result documentation
Assess system changes and upgrades for validation impact and coordinate appropriate testing activities
Lead implementation activities, mentor junior analysts, and provide subject-matter expertise to cross-functional teams

Requirements

Advanced degree plus 4+ years LIMS experience, or bachelor's degree plus 5+ years LIMS experience
Hands-on experience with Watson, SampleManager, or other Thermo Fisher LIMS platforms
Strong knowledge of GxP regulations, 21 CFR Part 11, Annex 11, and GAMP 5
Demonstrated experience authoring and executing IQ/OQ/PQ validation documentation
Background in pharma, biotech, CRO, or regulated laboratory environments
Direct client-facing experience in consulting, vendor, or services capacity
Understanding of SDLC methodologies and system implementation approaches

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Vacancy posted 7 days ago

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