Hybrid CSV Specialist – Pharma & Medical Devices Barcelona

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

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