Sr. System Validation, Platform Qualification Engineer

Role: System Validation, Platform Qualification

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Location: Spain(100% Remote)

Client: Infosys

Sal: Market Range

Permanent full-time position

Requirements and number of open positions

3-5 years- 2 Positions in Open

5-10 Years- 2 Positions in Open

10+ years - 2 Positins in Open

Role Overview

We are looking for a highly experienced Validation resource with 10+ years of experience in Computerized System Validation (CSV) within the Life Sciences domain. The candidate will lead end-to-end validation activities for enterprise-level software systems and manage teams, stakeholders, and delivery for global programs.

Key Responsibilities

- Lead end-to-end validation lifecycle (Planning, Risk Assessment, Testing, Release, Periodic Review)

- Drive validation strategy for enterprise programs across regions (Europe/Global)

- Manage validation teams, allocate work, and ensure timely delivery

- Act as primary point of contact for client stakeholders and leadership

- Lead governance, status reporting, and escalation management

- Author and review validation deliverables (URS, FRS, IQ/OQ/PQ, RTM, Validation Report)

- Ensure compliance with 21 CFR Part 11, EU Annex 11, Data Integrity (ALCOA+)

- Manage quality processes (Deviation, CAPA, Change Control)

- Support regulatory audits and inspection readiness

- Mentor and coach junior resources, build capability within the team

- Drive continuous improvement and standardization of validation processes

Managerial Skills

- Team leadership and people management

- Stakeholder and client relationship management

- Program and project management for global validation initiatives

- Risk and issue management with mitigation planning

- Resource planning and capacity management

- Governance, reporting, and executive communication

- Budget awareness and delivery management

- Cross-functional coordination across IT, QA, Business and Vendors

Required Skills & Competencies

- 10+ years of experience in Life Sciences CSV/CSA

- Exposure to cloud/SaaS validation

- Strong experience in enterprise systems (SAP S/4HANA, Veeva Vault, LIMS, QMS etc.)

- understanding of SDLC and validation lifecycle

- Understanding on regulatory guidelines (GAMP 5, GxP, 21 CFR Part 11, EU Annex 11 etc.)

- Experience in risk-based validation and CSA approach

- Experience working with US and European clients and regulated environments

- Strong documentation, communication, and leadership skills. xsgfvud

Hay opciones de teletrabajo/trabajo desde casa disponibles para este puesto.