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.

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📌 Computer System Validation Specialist (Barcelona)
🏢 Pqe Group
📍 Barcelona