Computerized Systems Validation (CSV) Specialist

Barcelona | Pharmaceutical Industry | Hybrid

Are you passionate about quality, compliance, and digital transformation within highly regulated environments?

We are looking for an experienced

Computerized Systems Validation (CSV) Specialist

to join a leading international pharmaceutical company and play a key role in ensuring that critical GxP computerized systems remain compliant, reliable, and inspection-ready throughout their lifecycle.

What you'll be doing
As a CSV Specialist, you will act as a trusted expert supporting validation activities across manufacturing, quality, laboratory, and business systems. You'll work closely with cross-functional stakeholders to ensure compliance while enabling innovation and digitalisation initiatives.

Your responsibilities will include:

Leading validation projects for computerized systems from implementation through retirement.

Defining validation strategies using risk-based approaches aligned with GAMP 5 principles.

Developing and reviewing validation documentation, including URS,



Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.

Supporting system upgrades, enhancements, infrastructure changes, and periodic reviews.

Ensuring compliance with GMP regulations, Data Integrity requirements, Annex 11, and 21 CFR Part 11.

Participating in audits and inspections as the CSV subject matter expert.

Managing validation-related deviations, CAPAs, and change controls.

Collaborating with Quality, IT, Manufacturing, Engineering, Laboratory and Regulatory teams.

Driving continuous improvement initiatives and supporting digital transformation programmes.

What we’re looking for

Previous experience in Computerized System Validation within a pharmaceutical, biotechnology, medical device, or other regulated environment.

Strong knowledge of GAMP 5, EU GMP Annex 11, Data Integrity (ALCOA+), and 21 CFR Part 11.

Experience validating GxP syste

📌 Computerized Systems Validation (Madrid)
🏢 Oxford Global Resources
📍 Madrid