Hybrid CSV Specialist: Regulated Systems Validation

Kymos Group; Barcelona; Híbrido; EUR 42.000 - 62.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible hours

Hybrid work model

Employee benefits platform

23 vacation days + December days

Descripción de la vacante

KYMOS GROUP, a growing CRO with HQ in Spain, seeks a Computer System Validation professional for the Barcelona area. You will support validation of laboratory and other computerized systems in regulated GxP environments, ensuring regulatory compliance and data integrity.

You will collaborate with QA, IT and Laboratory teams, handling validation plans, risk analyses, and test executions, while working in a hybrid setup near Cerdanyola del Vallès (Barcelona).

Formación

• University degree in Engineering, Chemistry, Physics, Pharmacy or related field.
• Experience or knowledge in computer system validation, quality, laboratory environments or regulated GxP environments.
• Familiarity with CSV lifecycle and documentation.

Responsabilidades

• Participate in computer system validation activities for laboratory equipment and other systems.
• Support preparation and review of Validation Plan, Risk Analysis, Design Review, IOPQ, Traceability Matrix, Final Validation Report.
• Collaborate on data integrity, regulatory compliance, and change control.
• Support preparation and execution of tests and user acceptance testing.
• Participate in periodic reviews of computerized systems.
• Collaborate with Quality Assurance, IT, LIMS and Laboratory teams on CSV projects.
• Support internal audits and CSV documentation.

Conocimientos

CSV validation

GxP compliance

LIMS

Empower

SCADA

ERP

Spanish

English

Educación

Engineering

Chemistry

Physics

Pharmacy

Herramientas

LIMS

Empower

SCADA

ERP

Descripción del empleo

KYMOS GROUP, a growing CRO with HQ in Spain, seeks a Computer System Validation professional for the Barcelona area. You will support validation of laboratory and other computerized systems in regulated GxP environments, ensuring regulatory compliance and data integrity.

You will collaborate with QA, IT and Laboratory teams, handling validation plans, risk analyses, and test executions, while working in a hybrid setup near Cerdanyola del Vallès (Barcelona).