IT CSV Consultant (2-5yrs)
Core
Ensuring compliance with regulatory requirements for GxP-regulated computerized systems within pharmaceutical, biotechnology, medical device, or life sciences environments.
Role type
IT CSV (Computer System Validation) Specialist
Builds
Validated GxP-regulated applications and infrastructure
Domain
Life Sciences / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GAMP 5, GxP, 21 CFR Part 11, Annex 11, Data Integrity, ALCOA+, SDLC, validation lifecycle methodologies, IQ/OQ/PQ protocols, risk-based validation
Preferred skills
Veeva Vault, TrackWise, LabWare LIMS, ERP, LMS, QMS, RIM, clinical systems, cloud-based applications, SaaS validation
Responsibilities
Execute CSV activities for GxP-regulated applications and infrastructure; Develop and review validation deliverables including Validation Plans, Risk Assessments, URS, FS, DS, IQ, OQ, PQ, Traceability Matrix, and Validation Summary Reports; Support system implementation, upgrades, migrations, and periodic reviews; Conduct risk-based validation in compliance with GAMP 5 guidelines; Collaborate with Quality, IT, Business, and Vendor teams throughout the validation lifecycle; Support audit and inspection readiness activities; Ensure compliance with 21 CFR Part 11, Annex 11, GxP, Data Integrity, and ALCOA+ principles; Assist in deviation management, CAPA implementation, and change control activities; Maintain validation documentation and ensure systems remain in a validated state.
