Junior Lab IT CSV Engineer for GMP Validation

SimoTechnology; Cork; Presencial; EUR 40 000 - 60 000; Tempo integral

Resumo da oferta

SimoTech is seeking a Junior Lab IT CSV Engineer to support laboratory system validation and compliance activities for a biopharma client in Co. Cork, Ireland.

You will assist in implementation, validation, and ongoing support of laboratory computerized systems, working with CSV, Quality, and IT professionals in a GMP environment to gain hands-on experience across system lifecycle activities.

Qualificações

• Bachelor's degree in Engineering, Computer Science, or related technical discipline.
• 1-3 years' experience in a regulated pharmaceutical, biotech, medical device, or lab environment.
• Basic understanding of CSV, SDLC, and GMP principles.
• Strong attention to detail and documentation skills.
• Good communication and teamwork abilities.
• Exposure to validation documentation and testing activities is advantageous.

Responsabilidades

• Support validation activities for laboratory computerised systems under supervision.
• Assist with preparation and execution of validation protocols and test scripts.
• Contribute to generation and maintenance of validation documentation.
• Participate in risk assessments, change controls, and document reviews.
• Support collection and organisation of validation evidence and test records.
• Assist with system periodic reviews and compliance monitoring activities.
• Coordinate with laboratory, quality and IT teams to resolve validation issues.
• Support inspection and audit readiness activities.
• Coordinate system and test data availability with laboratory teams.
• Ensure work adheres to GMP, Data Integrity, and company procedures.

Conhecimentos

Documentation skills

Attention to detail

Team collaboration

Good communication

Willingness to learn

Formação académica

Bachelor's degree in Engineering/Computer Science or related technical discipline

Ferramentas

LIMS

CDS

ELN

LabVantage

Descrição da oferta de emprego

SimoTech is seeking a Junior Lab IT CSV Engineer to support laboratory system validation and compliance activities for a biopharma client in Co. Cork, Ireland.

You will assist in implementation, validation, and ongoing support of laboratory computerized systems, working with CSV, Quality, and IT professionals in a GMP environment to gain hands-on experience across system lifecycle activities.