We are looking for Validation Engineer

e-stonetech; Gurgaon; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

A leading IT solutions company in Gurgaon is looking for an experienced IT Applications Lead. This role requires strong expertise in business–IT liaison, project management, and GxP compliance. The ideal candidate will manage project timelines and deliverables while providing support for critical IT applications. A solid understanding of system validation and regulatory guidelines is essential. Excellent communication and stakeholder management skills are required to bridge gaps between teams and ensure compliance throughout the application lifecycle.

Qualifications

• Expertise in understanding business requirements and proposing optimal system solutions.
• Strong skills in managing project timelines and deliverables.
• Hands-on experience with CSV, 21 CFR Part 11, GAMP 5 guidelines.

Responsibilities

• Act as a bridge between business users, QA, and external IT vendors.
• Lead end-to-end project lifecycle including planning, execution, and closure.
• Provide Level-2/Level-3 support for critical IT applications.
• Plan and execute end-to-end validation of computerized systems.
• Prepare and review validation documents such as URS, FRS, IQ/OQ/PQ.

Skills

Business–IT liaison

Stakeholder management

Vendor coordination

System validation

Analytical skills

Problem-solving abilities

Communication skills

Job description

Experienced IT Applications Lead with strong expertise in business–IT liaison, stakeholder management, vendor coordination, and end‑to‑end system validation in GxP-regulated environments. Skilled in understanding business requirements, proposing optimal system solutions, and ensuring compliance with global quality and regulatory standards throughout the application lifecycle.

Key Responsibilities

Business–IT Coordination

Act as a bridge between business users, QA, and external IT vendors.

Gather, analyse, and translate business requirements into functional specifications.

Suggest feasible technical solutions aligned with business needs and compliance standards.

Project Management

Lead end‑to‑end project lifecycle including planning, execution, monitoring, and closure.

Manage project timelines, deliverables, risks, and resource coordination.

Conduct periodic project review meetings and ensure timely reporting to stakeholders.

Application Support & Lifecycle Management

Provide Level‑2/Level‑3 support for critical IT applications.

Ensure application stability, performance, and availability.

Oversee periodic review of systems and ensure documentation accuracy.

GxP Compliance & Validation

Plan and execute end‑to‑end validation of computerized systems (CSV).

Prepare and review validation documents (URS, FRS, IQ/OQ/PQ, Traceability Matrix, Reports).

Ensure systems meet 21 CFR Part 11, GAMP 5, and other regulatory guidelines.

Quality Management System (QMS)

Prepare QMS records such as:

• Deviations
• Change Controls
• CAPA
• Incidents & Investigations

Ensure adherence to internal quality procedures and regulatory requirements.

Coordinate with external vendors for system development, enhancements, and issue resolution.

Manage stakeholder expectations and ensure smooth communication across teams.

Support system design, implementation, configuration, and migrations.

Manage upgrades, patching, and release cycles.

Ensure alignment with organizational IT and data integrity policies.

Strong understanding of SDLC and validation lifecycle in GxP systems.

Hands‑on experience with CSV, 21 CFR Part 11, GAMP 5 guidelines.

Expertise in IT application management and support.

Experience in reviewing technical/validation documentation.

Excellent communication, stakeholder management, and vendor handling skills.

Strong analytical and problem‑solving abilities.

Ability to manage multiple projects in parallel.