Sr Validation Specialist (LIMS)
Core
Provide technical expertise for LIMS products and computer system validation (CSV) in regulated environments.
Role type
Senior Validation Specialist (LIMS)
Builds
Validated LIMS solutions for pharma, biotech, and regulated laboratory clients
Domain
Life Sciences / Regulatory Compliance / Computer System Validation
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
LIMS implementation and configuration, Computer System Validation (CSV) documentation, GxP/GLP compliance, IQ/OQ/PQ testing, Change control management, SDLC methodologies, Client consulting
Preferred skills
Thermo Fisher SampleManager/Watson LIMS platform knowledge, Agile delivery models, Test management systems
Technologies
LIMS platforms, Validation tools, ITSM platforms
Responsibilities
Implement and configure LIMS products, Develop and execute validation documentation (requirements, risk assessments, protocols, reports), Perform functional/regression/UAT testing, Ensure compliance with GxP/21 CFR Part 11, Manage change control and system upgrades, Lead validation activities and support audits
Seniority
Senior, hands-on IC with client-facing responsibilities