We are seeking a detail-oriented and experienced Lab System Validation Analyst to support validation efforts for computerized laboratory systems in regulated (GxP) environments. This role combines core LSV responsibilities with hands‑on involvement in system setup, configuration, and ongoing support, ensuring laboratory systems are compliant, functional, and operationally stable. The analyst will partner closely with Quality, IT, Lab Operations, and external vendors across the full system lifecycle.
Scope of Services
Chromatography Data Systems (CDS) (e.g., Empower, OpenLab)
Laboratory Information Management Systems (LIMS)
Electronic Lab Notebooks (ELN)
Scientific Data Management Systems (SDMS)
Laboratory instruments (e.g., HPLC, GC, mass spectrometers, bioreactors)
Instrument-integrated environments and supporting infrastructure
Key Responsibilities
Validation (Core LSV Responsibilities)
Execute CSV activities aligned with GAMP 5
Author/review URS, FRS/DS, RTM, IQ/OQ/PQ, validation reports
Perform risk/impact assessments and support change control
Ensure compliance with 21 CFR Part 11, Annex 11, ALCOA+
Maintain validated state and support audits
Technical Configuration & System Support
Support system configuration, setup, and deployment
Perform installation and qualification (IQ/OQ)
Assist with application configuration and system settings
Support instrument connectivity and data flows
Troubleshoot issues and coordinate with vendors/IT
Support upgrades, patches, and environment updates
Application Administration & Technical Operations
User/role configuration
Access management and reviews
Backup/restore verification
System health checks and troubleshooting
Vendor coordination and support
Collaboration & Lifecycle Management
Partner with QA, IT, Lab Operations
Support lifecycle management and documentation
Validation Plans and Reports
URS, FRS/DS, RTM
IQ/OQ/PQ Protocols and execution
System configuration documentation
Technical support documentation
Audit‑ready documentation
Required Qualifications
Bachelor’s degree (Life Sciences, Engineering, CS or related)
3+ years in GxP lab systems
Experience in CSV and technical configuration/support
Experience with CDS, LIMS, ELN, SDMS
Knowledge of GAMP 5, Part 11, Annex 11, ALCOA+
Experience with IQ/OQ/PQ
Preferred Skills
Experience with Empower, LabWare/LabVantage, OpenLab, Signals ELN
Familiarity with Windows lab environments
Validation tools (ValGenesis, Kneat, HP ALM)
System upgrades and migrations
Performance Expectations
Systems validated and operational
Independent troubleshooting capability
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