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87,000+ live jobsHybrid in Sant Cugat del Vallès·Added 6 days ago (last checked 15 Oct)
15 open roles
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This job advert was originally written in Spanish.
REQUIREMENTS 🤹:
Previous experience in Computer System Validation (CSV) within the pharmaceutical or Life Sciences sector.
Experience in validation of computerized systems, corporate applications, and integrations with GxP impact.
Experience in the preparation and execution of validation protocols, test scripts, risk analyses, and reports.
Knowledge of GxP regulations in the pharmaceutical sector.
Knowledge of 21 CFR Part 11 and EU GMP Annex 11 regulations.
Knowledge of GAMP 5 and risk-based validation methodologies.
Experience in change management (Change Control), deviations, and corrective and preventive actions (CAPA).
Knowledge of data integrity, electronic records, and audit trails.
University studies in Engineering, Computer Science, Pharmaceutical Sciences, or related technical disciplines.
Proficiency in English, both spoken and written.
Ability to communicate and coordinate with IT, QA, Automation, and Production teams.
Experience with ServiceNow or other similar corporate platforms.
Experience in validation of GxP applications, integrations, and automated testing frameworks.
Knowledge of industrial systems and connectivity platforms with manufacturing equipment.
Experience in pharmaceutical manufacturing environments and international projects.
Salary negotiable based on experience and knowledge.
Permanent contract.
Meal vouchers on the days you go to the office.
Flexible compensation plan (with tax advantages according to applicable regulations): private medical insurance, public transport, and childcare vouchers.
Discounts to access fitness centers
Learning and development through a training catalog.
Referral program.
An organization with highly qualified professionals with whom to grow and develop.
Definition and implementation of risk-based computerized system validation strategies.
Generation and maintenance of validation documentation: validation plans, risk analyses, test protocols, traceability matrices, and final reports.
Planning, execution, and review of functional and integration tests for GxP systems and applications.
Validation of new modules, functionalities, and integrations in corporate applications.
Evaluation of the impact of changes on validated systems and determination of revalidation needs.
Maintenance of the validated state of systems throughout their entire life cycle.
Management and monitoring of change controls, deviations, and incidents, as well as associated CAPA actions.
Review of test evidence and ensuring traceability between requirements, risks, and results.
Collaboration with IT, QA, Automation, Production teams, and external providers.
Preparation of documentation and evidence for internal and external audits.
Communication of project status, identified risks, and detected incidents.
Participation in continuous improvement initiatives for validation processes and regulatory compliance.
Monday to Friday, from 8:00-9:00 h to 17:00-18:00 h (flexible schedule).
Hybrid work model.
Location: Sant Cugat del Vallès.
Ambit Iberia is a specialized consultancy providing IT and engineering services to the pharmaceutical and life sciences sectors, with a strong focus on regulated environments. The company supports clients with digital transformation, data integrity, and compliance-driven projects, offering services such as system validation, MES engineering, cybersecurity, and cloud-based software development. Operating primarily in Spain and Portugal, Ambit Iberia positions itself as a niche partner for pharma companies seeking technical expertise in highly regulated settings.
With its main office in Barcelona, Ambit Iberia serves as the Spanish arm of a broader international group, delivering projects across Europe. The company's work culture emphasizes technical excellence and regulatory compliance, making it an attractive option for international professionals with backgrounds in pharma IT, validation, and engineering. Many roles are offered as fully remote or hybrid, allowing flexibility for candidates based in Spain or Portugal, and the company actively seeks talent with experience in GxP environments and modern cloud technologies.
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