Sr. System Validation, Platform Qualification Engineer - Nityo Infotech

Role: System Validation, Platform Qualification

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.

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