CSV Senior Validation Engineers

Syspro Automation; Madrid; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

Syspro Automation in Madrid is seeking CSV (Computerized System Validation) Engineers to join a multidisciplinary team working on challenging automation projects within a GMP environment.

You will conduct risk analyses, define validation plans for process equipment, review documentation to ensure compliance, define and execute qualification tests, and manage deviations and changes. English level C1 is required; knowledge of Kneat is a plus, and Spanish or Portuguese language skills are welcome.

Formación

• Minimum of 8 years of experience in CSV validation.
• Strong skills in managing and creating documentation (Word/Excel).
• Excellent communication skills and proactive attitude.
• Ability to work independently and as part of a team.
• Experience in biotech with knowledge of cGMP.

Responsabilidades

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

Conocimientos

CSV validation

Documentation

Communication

Independent work

cGMP knowledge

English Proficiency

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.

Syspro Automation is an engineering company focused on GMP Automation, working globally with offices in Spain, Portugal, Switzerland and the United States.

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 8 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 C1 or better.

Skills that would be a plus:

• Knowledge of Kneat documentary platform is a plus.
• Spanish or portuguese language is also a plus.

We offer:

• Permanent contract.
• Integration into a young and highly skilled team.
• Opportunities for professional development and continuous training.