Computer System Validation Consultant

JR Spain; Moreda de Álava; Híbrido; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading consulting firm in the pharmaceutical sector is seeking a Computer System Validation Consultant to join its team in Spain. This hybrid position requires strong Spanish language skills and at least 1–3 years of experience in the pharmaceutical industry. The role involves supporting GxP compliance, preparing technical documentation, and working with clients on validation projects. PQE Group offers a dynamic work environment with opportunities for professional growth and collaboration on international projects.

Formación

• 1–3 years of experience in the Pharmaceutical industry or in a related validation/qualification role.
• Basic to intermediate understanding of GxP regulations, 21 CFR Part 11, EU Annex 11, and other compliance requirements.
• Good command of English (B1–B2) necessary.

Responsabilidades

• Contribute to the execution of CSV projects, ensuring alignment with GxP requirements.
• Assist in drafting and reviewing technical documents such as validation plans and protocols.
• Work closely with IT and Quality Assurance to ensure proper compliance implementation.

Conocimientos

Spanish language skills

Technical documentation preparation

GxP regulations understanding

Organizational skills

Teamwork attitude

Problem-solving mindset

Educación

Bachelor’s or Master’s degree in Scientific or Technical disciplines

Herramientas

Test management tools

CSV-related tools

Descripción del empleo

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Client:

PQE Group

Location:

Job Category:

Other

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EU work permit required:

Yes

Job Reference:

770950531395040051232460

Job Views:

1

Posted:

06.12.2025

Expiry Date:

20.01.2026

Job Description:

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries ? PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas .

Due to a constant growth, we are looking for a Computer System Validation Consultant to join our team in Barcelona or Madrid, Spain.

❗ This is a hybrid role (2 days working from home ) and requires strong Spanish language skills at a professional level.

Responsibilities

• Support in Computer System Validation (CSV) activities: Contribute to the execution of CSV projects, ensuring alignment with GxP requirements, 21 CFR Part 11, EU Annex 11, and applicable guidelines.
• Preparation of validation documentation: Assist in drafting and reviewing technical documents such as validation plans, protocols (IQ/OQ/PQ), reports, and risk assessments.
• Execution of testing activities: Participate in protocol execution, test result documentation, and deviation management as needed.
• Support in risk assessments: Collaborate in collecting information, performing preliminary risk analyses, and defining mitigation actions.
• Cross-functional collaboration: Work closely with IT, Quality Assurance, and other business functions to ensure proper implementation of compliance requirements.
• Regulatory awareness: Stay informed about relevant regulations and industry best practices related to computer system validation.
• Client support: Provide operational and consulting support to clients during CSV activities.

Requirements:

• Bachelor’s or Master’s degree in Scientific or Technical disciplines (Pharmacy, Chemistry, Biology, Engineering, Computer Science, etc.).
• 1–3 years of experience in the Pharmaceutical industry or in a related validation/qualification role.
• Basic to intermediate understanding of GxP regulations , 21 CFR Part 11 , EU Annex 11 , and other compliance requirements.
• Native-level Spanish (mandatory) and good command of English (B1–B2).
• Familiarity with GxP-regulated computer systems , test management tools, and CSV-related tools.
• Strong skills in technical documentation preparation and updating.
• Good organizational skills , teamwork attitude, problem-solving mindset, and motivation to grow in the CSV consulting field.

Location: Barcelona or Madrid, Spain

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.

If there's a positive match, a technical interview with the Hiring Manager will be arranged.

In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.

Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation . PQE Group gives you the opportunity to work on international projects , improve your skills and interact with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career , PQE Group is the perfect place for you.

Apply now and take the first step towards an amazing future with us.