Computerized Systems Validation (CSV) Specialist

Oxford Global Resources; Barcelona; Híbrido; EUR 55.000 - 75.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work model

Competitive compensation

Descripción de la vacante

Oxford Global Resources in Barcelona is seeking a Computerized Systems Validation (CSV) Specialist to ensure GxP computerized systems stay compliant, reliable, and inspection-ready throughout their lifecycle.

You will lead validation projects, apply risk-based methods per GAMP 5, develop IQ/OQ/PQ docs, support upgrades, audits, and cross-functional collaboration in a fast-paced pharmaceutical environment. This role offers international exposure and a focus on continuous learning.

Formación

• Experience in Computerized System Validation within pharmaceutical/regulated environments.
• Knowledge of GAMP 5, EU GMP Annex 11, Data Integrity (ALCOA+), and 21 CFR Part 11.

Responsabilidades

• Lead validation projects for computerized systems from implementation through retirement.
• Define validation strategies using risk-based approaches.
• Develop and review validation documentation (URS, IQ/OQ/PQ, Traceability Matrices, Validation Reports).
• Support system upgrades, infrastructure changes, and periodic reviews.
• Ensure GMP compliance and participate in audits/inspections as CSV SME.
• Manage deviations, CAPAs, and change controls.
• Collaborate with Quality, IT, Manufacturing, Engineering, Laboratory and Regulatory teams.
• Drive continuous improvement and digital transformation initiatives.

Conocimientos

GxP validation

Risk-based validation

Stakeholder management

Cross-functional collaboration

Descripción del empleo

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 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.
• Competitive compensation and benefits package.

Interested in helping shape the future of compliant digital systems in the pharmaceutical industry? We'd love to hear from you.