Computerized System Validation Specialist
Core
Safeguard patient safety and product quality by ensuring GxP computerized systems remain compliant throughout their lifecycle via risk-based validation practices.
Role type
Computerized System Validation Specialist (Quality Management)
Builds
Validated GxP applications, platforms, and digital solutions for pharmaceutical and biotechnology customers.
Domain
Pharmaceutical / Biotechnology / Regulated GxP environments
Required skills
GxP regulations (EU GMP Annex 11/15, FDA 21 CFR Part 11, GAMP 5), risk-based validation lifecycle management, data integrity principles (ALCOA+), audit and inspection readiness, supplier assessment, change management, CAPA, traceability matrices, user requirements specifications (URS), test protocols, deviation management, electronic signatures, audit trails, access controls, data migration, backup/restore, business continuity, cloud/SaaS validation, LIMS/MES/eQMS experience.
Preferred skills
Regulatory impact assessments, gap assessments, remediation programs, coaching/training on GxP and data integrity, harmonization of global CSV practices, automated testing tools, requirements management platforms.
Technologies
LIMS, CDS, MES, eQMS, ERP, Cloud/SaaS platforms, Automated testing tools, Requirements management platforms.
Responsibilities
Own and apply the risk-based CSV framework for GxP applications; Ensure compliance with applicable pharmaceutical requirements and recognized industry guidance; Embed quality and compliance requirements from project initiation through retirement; Maintain regulatory watch and translate new expectations into practical standards; Act as CSV subject-matter expert during internal audits, customer audits and Health Authority inspections; Assess GxP impact and define a proportionate validation strategy; Review and approve validation deliverables including URS, risk assessments, and test protocols; Ensure end-to-end traceability from GxP requirements to acceptance criteria; Confirm validation readiness and issue Authorization for Use; Provide quality oversight for changes, upgrades, incidents, and system retirement; Partner with Quality, business and Digital/IT teams to integrate compliance by design; Coach and train System Owners and project teams on GxP and data integrity.
Seniority
Mid-level, hands-on IC