CSV Analyst with Instrument integration & Validation expertise
Core
Ensure systems operate reliably and remain in a validated state in accordance with EMA and GxP requirements by bridging technical software validation, testing, and regulatory compliance for laboratory, manufacturing, and embedded software systems.
Role type
Senior Instrument Integration & Validation Analyst
Builds
Validated laboratory, manufacturing, and embedded software systems
Domain
Pharmaceutical/Biotech/Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computer System Validation (CSV), Instrument integration, IQ/OQ/PQ protocol development, 21 CFR Part 11 compliance, GAMP 5, data integrity principles, LIMS, Chromatography Data Systems (Empower), FMEA, change control management
Preferred skills
Experience with legacy SOP transitions, cross-functional collaboration
Technologies
LIMS, Empower, Instrument Manager, LIS
Responsibilities
Validate software used in laboratory and manufacturing instruments in compliance with FDA, EMA, and GxP guidelines; Author and maintain validation documentation such as Validation Plans, Reports, URS, Functional/Design Specifications, and Traceability Matrices; Perform functional, integration, regression, and data integrity testing; Conduct risk assessments (FMEA) to identify and mitigate system risks; Gather and document system requirements and develop software specifications and validation test cases
Seniority
Senior, hands-on IC
