Computer System Validation (CSV) Specialist NL
Core
Ensuring compliance, reliability, and audit-readiness of computerized systems in life sciences through Computer System Validation (CSV) and data integrity management.
Role type
Computer System Validation (CSV) Specialist
Builds
Validated GxP-compliant IT systems and software solutions for life sciences clients
Domain
Life Sciences / Regulatory Compliance / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
GAMP5 principles, GxP regulations (USFDA 21 CFR Part 11, Eudralex Annex 11), risk-based approach, data integrity (ALCOA+), MES systems, validation planning, protocol writing, change control management, supplier software assessment
Preferred skills
Life Sciences industry experience, software-driven project experience, analytical mindset, project management, training and mentoring
Technologies
Manufacturing Execution Systems (MES), GxP-compliant software platforms
Responsibilities
Own validation activities from start to finish for GxP-relevant systems; Apply GAMP5 guidelines using a risk-based approach; Write and review user requirements, validation plans, protocols, reports, and risk assessments; Champion data integrity and embed ALCOA+ principles; Collaborate with QA, IT, engineering, and operations; Plan periodic reviews and revalidation; Execute required tests with Production and QC; Act as expert during audits and inspections; Tackle change controls; Assess supplier-provided software systems; Train and guide colleagues
Seniority
Mid-level, hands-on IC