CSV Engineers

Syspro Automation; Gijón; Híbrido; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

Syspro Automation is seeking a CSV Engineer to join their multidisciplinary team involved in automation projects within a GMP environment. This role includes conducting risk analysis, managing documentation, and ensuring compliance in the pharmaceutical industry.

Servicios

Permanent contract

Remote or hybrid work options

Opportunities for professional development

Continuous training

Formación

• Minimum 5 years of experience in CSV validation.
• Experience in the biotech industry with knowledge of cGMP.
• English level B2 or better.

Responsabilidades

• Conduct risk analysis and define validation plans for pharmaceutical process equipment.
• Review documentation to ensure compliance with validation plan.
• Manage and document deviations and changes.

Conocimientos

Documentation management

Excellent communication

Proactive attitude

Independent work

Team collaboration

Descripción del empleo

In Syspro Automation we are looking for CSV (Computerized System Validation) Engineers to join a multidisciplinary team working in challenging automation projects within a GMP environment.

Main responsibilities :

• Conduct risk analysis and define validation plans for various process equipments in the pharmaceutical industry.
• Review documentation of the equipments to ensure compliance with the validation plan.
• Define, execute and document qualification tests.
• Manage and document deviations and changes.

Required skills and experience :

• Minimum of 5 years of experience in CSV validation.
• Strong skills in managing and creating documentation (Microsoft Word and Excel).
• Excellent communication skills and proactive attitude.
• Ability to work independently and as part of a team.
• Experience within the biotech industry with knowledge of current Good Manufacturing Procedures (cGMP).
• English level B2 or better.

Skills that would be a plus :

• Experience with DeltaV systems is a strong plus.
• Knowledge of Kneat documentary platform is a plus.

We offer :

• Permanent contract.
• Remote or hybrid work options in our offices in Nigrán, Madrid and Lisbon.
• Integration into a young and highly skilled team.
• Opportunities for professional development and continuous training.

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