CSV Engineer ( 12 Months Contract )
Core
Manage, coordinate, and execute validation deliverables for new Information System (IS) projects in a pharmaceutical/biotech environment to ensure regulatory compliance.
Role type
Computer System Validation (CSV) Engineer
Builds
Validated computerized systems (ERP, MES, LIMS, Quality Systems) for pharmaceutical/biotech clients
Domain
Healthcare / Pharmaceutical / Biotechnology / Regulatory Compliance
Deliverable
client delivery
Required skills
Computer System Validation (CSV), GxP regulations (21 CFR Part 11, EU GMP Annex 11), Computerized System Development Life Cycle (CS-CDL), Validation planning, Risk assessment, Traceability matrix creation, IQ/OQ/PQ testing, Data migration, SOP development, Change control management
Preferred skills
ERP, MES, LIMS, Quality Systems validation experience
Technologies
ERP, MES, LIMS
Responsibilities
Prepare Validation/Qualification Plans, Risk Assessments, User Requirement Specifications, Traceability Matrices, and Test Protocols (IQ, OQ, PQ); Ensure compliance with regulatory requirements and company policies; Support resolution of project deviations and provide quality guidance on GxP requirements; Conduct validation training for project teams
Seniority
Mid-level, hands-on IC
