Computerized System Validation (CSV) Manager

REQUIREMENTS 🤹 : Previous experience in Computer System Validation (CSV) within the pharmaceutical or Life Sciences sector.

Experience in the validation of computerized systems, corporate applications, and integrations with GxP impact.

Experience in the preparation and execution of validation protocols, test scripts, risk analysis, 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 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.

It will be valued: Experience with ServiceNow or other similar corporate platforms.

Experience in the 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.

TASKS 🚀 : 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.

Assessment 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 vendors.

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.

SCHEDULE 🕘 : Monday to Friday, from 8:00-9:00 h to 17:00-18:00 h (flexible schedule).

Hybrid modality

Location: Sant Cugat del Valles.

CONDITIONS 🌱 : Salary negotiable based on experience and knowledge.

Indefinite contract.

Restaurant voucher on the days you go to the office.

Flexible remuneration 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.