GxP Validation Engineer (Client - Facing)

Job Overview

The GxP Consultant / Client-Facing Validation Engineer is responsible for delivering end-to-end validation and compliance consulting services to pharmaceutical, biotechnology, and medical device clients.

This role combines Computer System Validation (CSV) with Equipment, Utilities, and Facilities Qualification, ensuring compliance with global regulatory standards including U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), 21 CFR Part 11, EU Annex 11, and GAMP 5 principles.

The consultant acts as a trusted client advisor, ensuring systems, processes, infrastructure, and manufacturing assets are validated, audit-ready, and continuously compliant.

Key Responsibilities

Act as primary validation contact for clients.

Conduct validation discussions, project status meetings, and workshops.

Support client audits, inspections, and compliance reviews.

Execute validation lifecycle activities for GxP systems .

Prepare validation documentation including:

Validation Plan

Risk Assessment

Software Assessment

User Requirements Specification (URS)

Functional Requirements Specification (FRS)

IQ / OQ / PQ Protocols

Traceability Matrix

Validation Summary Report

Support qualification of pharmaceutical manufacturing and laboratory equipment.

Review FAT/SAT documentation and support equipment validation activities.

Support qualification of utilities and facilities systems including:

HVAC systems

Cleanrooms

Water systems (PW/WFI)

Compressed air systems

Environmental monitoring systems

Change Control Management

Perform validation impact assessments for system or equipment changes.

Update validation documentation and testing requirements.

Support Change Control processes and revalidation activities.

Documentation & eDMS Management

Manage validation documentation in eDMS platforms.

Ensure document version control, approval workflows, and audit readiness.