Lab Validation Analyst - Near Dublin - €600 - €700 per day

Lab System Validation (LSVLSV) Analyst - Technical/Hybrid Profile - €600 - €700 per day - County Meath, Meath, Ireland - 6 months

Role Summary
The Lab System Validation (LSVLSV) Analyst will support both validation (CSVCSV) and technical configuration/support activities for laboratory systems, instruments, and equipment within GxPGxP-regulated environments. This role combines core LSVLSV 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 lifecyclelifecycle.

Scope of Services
- Chromatography Data Systems (CDS) (eg, Empower, OpenLabOpenLab)
- Laboratory Information Management Systems (LIMSLIMS)
- Electronic Lab Notebooks (ELNELN)
- Scientific Data Management Systems (SDMSSDMS)
- Laboratory instruments (eg, HPLCHPLC, GCGC, mass spectrometers, bioreactors)
- Instrument-integrated environments and supporting infrastructure

Key Responsibilities
Validation (Core LSVLSV Responsibilities)
- Execute CSVCSV activities aligned with GAMPGAMP 5
- Author/review URSURS, FRSFRS/DSDS, RTMRTM, IQ/OQOQ/PQPQ, validation reports
- Perform risk/impact assessments and support change control
- Ensure compliance with 21 CFRCFR 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/OQOQ)
- 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 & LifecycleLifecycle Management
- Partner with QA, IT, Lab Operations
- Support deviations, CAPAsCAPAs, incidents
- Support lifecyclelifecycle management and documentation

Deliverables
Deliverables - Validation Plans and Reports
- URS,URS FRS/FRSDS,DS RTM
RTM - IQ/OQ/OQPQ PQProtocols 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 GxPlab systems
- Experience in CSV CSVand technical configuration/support
- Experience with CDS, LIMS,LIMS ELN,ELN SDMS
SDMS - Knowledge of GAMP GAMP5, Part 11, Annex 11, ALCOA+
- Experience with IQ/OQ/OQPQ
PQ

Preferred Skills
- Experience with Empower, LabWare/LabWareLabVantage,LabVantage OpenLab,OpenLab Signals ELN
ELN - Familiarity with Windows lab environments
- Instrument integration experience
- Validation tools (ValGenesis,ValGenesis Kneat,Kneat HP ALM)ALM
- System upgrades and migrations

Performance Expectations
- Systems validated and operational
- Independent troubleshooting capability
- Audit-ready deliverables
deliverables - Strong cross-functional collaboration

Engagement Model
- Supports project and operational work
- Reports to Validation/Technical Leads
- Works across multiple systems

This temporary contract is inside IR35 IR35and will require working under the direction of the client delivery manager as part of a multi-disciplinary team. The successful candidate will follow established delivery processes and working practices

Lab System Validation (LSV)LSV Analyst - Technical/Hybrid Profile - €600 - €700 per day - County Meath,Meath Ireland

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