CQV Lab Engineer: QC Instrument Qualification & LIMS

SimoTechnology; Cork; Presencial; EUR 60.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Autonomy

Skills development

Capital projects with large clients

Descripción de la vacante

SimoTech is seeking a QC Laboratory CQV Engineer to support a leading pharmaceutical client in Cork. You will join a LabVantage LIMS implementation and act as a Business SME for the QC lab, coordinating instrument qualification and LIMS integration with the client’s SME.

The role demands strong IQ/OQ/PQ discipline and data integrity focus. The ideal candidate has 3+ years of CQV/validation experience in GMP environments and will manage multiple qualification packages while aligning with QC

Formación

• 3+ years of CQV, validation, or quality engineering experience in Life Sciences.
• Hands-on qualification of QC laboratory equipment and analytical instrumentation.
• Experience with IQ/OQ/PQ protocols and computer system validation.
• Familiarity with GMP, GDP and data integrity practices.

Responsabilidades

• Represent the QC Laboratory as a Business SME in instrument qualification and LIMS integration.
• Review and approve IQ, OQ, PQ protocols and executed records; support their execution.
• Coordinate instrument vendors and site visits; review vendor qualification packages.
• Review and approve validation documentation, configuration, installation and audit trails.
• Provide laboratory workflow input to LIMS configuration and data transfer.
• Coordinate downtime, data backup and data migration activities.
• Support change controls, deviations, and discrepancies through to closure.
• Review qualification summary reports and lifecycle management documentation.
• Participate in user acceptance testing and assist go-live of qualified instruments.
• Ensure GMP, GDP, and data integrity compliance throughout all project phases.

Conocimientos

CQV experience

Validation

Troubleshooting

Cross-functional collaboration

Educación

Bachelor's or Master's in Engineering/Science/Pharmaceuticals

Herramientas

LabVantage LIMS

LIMS implementation

Descripción del empleo

SimoTech is seeking a QC Laboratory CQV Engineer to support a leading pharmaceutical client in Cork. You will join a LabVantage LIMS implementation and act as a Business SME for the QC lab, coordinating instrument qualification and LIMS integration with the client’s SME.

The role demands strong IQ/OQ/PQ discipline and data integrity focus. The ideal candidate has 3+ years of CQV/validation experience in GMP environments and will manage multiple qualification packages while aligning with QC