Computerized Systems Validation (CSV) Specialist

Oxford Global Resources; Barcelona; Híbrido; EUR 70.000 - 110.000; Jornada completa

Descripción de la vacante

Oxford Global Resources in Barcelona is seeking an experienced Computerized Systems Validation (CSV) Specialist for a hybrid pharmaceutical environment. You will lead validation projects across manufacturing, quality, and laboratory systems, ensuring GxP compliance and inspection readiness throughout their lifecycle.

The role requires deep knowledge of GAMP 5, Annex 11, and ALCOA+ data integrity, plus experience with MES/LIMS/QMS/ERP/SCADA and risk-based validation methods.

Formación

• Experience in Computerized Systems Validation within regulated environments (pharma/biotech/medical devices).
• Strong knowledge of GAMP 5, EU GMP Annex 11, Data Integrity (ALCOA+), and 21 CFR Part 11.
• Experience validating GxP systems (MES/LIMS/QMS/ERP/SCADA) and manufacturing applications.
• Risk-based validation methodologies understandings.
• Excellent stakeholder management and communication skills.
• Ability to work across multidisciplinary teams.

Responsabilidades

• Lead validation projects for computerized systems from implementation through retirement.
• Define validation strategies using risk-based approaches aligned with GAMP 5.
• Develop and review validation documentation (URS, Risk Assessments, IQ/OQ/PQ, Traceability Matrices, Validation Summary Reports).
• Support system upgrades and periodic reviews, infrastructure changes.
• Ensure GMP, Data Integrity, Annex 11, and 21 CFR Part 11 compliance.
• Participate in audits and 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

GAMP 5

EU GMP Annex 11

Data Integrity

21 CFR Part 11

Stakeholder management

Communication

Cross-functional teams

GxP systems validation

MES

LIMS

QMS

ERP

SCADA

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.