CSV Specialist
Core
Ensuring automated isolator systems are validated in compliance with regulatory expectations using a paper-based validation approach.
Role type
Computer System Validation (CSV) Specialist
Builds
Validated isolator systems and associated software platforms for pharmaceutical/biotech clients
Domain
Life Sciences / Pharmaceutical Manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computer System Validation (CSV), isolator systems validation, paper-based validation documentation, GAMP 5 methodologies, risk-based validation, IQ/OQ/PQ protocols, traceability matrices, regulatory standards compliance (GxP, 21 CFR Part 11, Annex 11), automation systems familiarity (PLC, SCADA, HMI), data integrity principles (ALCOA+)
Preferred skills
Engineering or Life Sciences degree background, experience in pharmaceutical/biotech environments, stakeholder communication
Technologies
PLC, SCADA, HMI, GAMP 5
Responsibilities
Lead and execute CSV activities for isolator systems, develop validation deliverables (VMP, URS, FS/DS, Risk Assessments, IQ/OQ/PQ), support system lifecycle validation, manage paper-based validation documentation, review vendor documentation, support deviations and change control
Seniority
Mid-Senior, hands-on IC