Computerized Systems Validation (CSV) Specialist

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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:

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- 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

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- 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 systems such as MES, LIMS, QMS, ERP, SCADA, laboratory systems, or manufacturing applications.

- Understanding of risk-based validation methodologies.

- Excellent stakeholder management and communication skills.

- Ability to work effectively across multidisciplinary teams.

- Opportunity to work with cutting-edge digital and automated systems.

- Exposure to high-impact projects supporting pharmaceutical manufacturing and quality operations.

- International, collaborative, and innovation-driven environment.

- Strong focus on professional development and continuous learning. xcskxlj

- Competitive compensation and benefits package.

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📌 Computerized Systems Validation (CSV) Specialist (Barcelona)
🏢 Oxford Global Resources
📍 Barcelona