Computerized Systems Validation
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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.
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