Computer System Validation Specialist

PQE Group; Barcelona; Hybrid; EUR 50,000 - 65,000; Full time

Job summary

PQE Group is hiring a Computer System Validation Specialist in Barcelona, Spain. The role is hybrid (2 days working from home) and requires strong Spanish language skills at a professional level and good English.

You will contribute to CSV projects, draft validation documents, perform testing, and collaborate across IT, QA and business functions to ensure regulatory compliance. Ideal candidates hold a scientific/technical degree with 3+ years in the pharmaceutical sector or related validation

Qualifications

• Bachelor’s or Master’s degree in Scientific or Technical disciplines.
• 3+ years in pharmaceutical or related validation roles.
• Knowledge of GxP, 21 CFR Part 11, EU Annex 11 and related compliance.

Responsibilities

• Contribute to execution of CSV projects aligned with GxP and regulatory guidelines.
• Prepare validation docs: validation plans, protocols, reports, risk assessments.
• Execute testing activities and document results, manage deviations.
• Collect information, perform risk analyses, define mitigations.
• Collaborate with IT, QA and business units on compliance implementations.
• Stay updated on regulations and best practices for CSV.
• Provide operational and consulting support to clients during CSV activities.

Skills

Spanish (native)

English (B1-B2)

GxP regulations

21 CFR Part 11

EU Annex 11

CSV regulatory knowledge

Technical documentation

Organizational skills

Teamwork

Education

Scientific or Technical degree (Pharmacy, Chemistry, Biology, Engineering, CS)

Tools

Test management tools

CSV-related tools

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 Specialist to join our team in Barcelona, Spain.

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

Responsibilities

include, but are not limited, to the following:

• 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.
• 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.).
• +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.

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.