Descripción de la oferta
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 experiencedComputerized Systems Validation (CSV) Specialistto 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.#J-18808-Ljbffr
