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. #J-18808-Ljbffr

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