Overview

We are seeking an experienced Validation Engineer to support commissioning, qualification, and validation activities within a GMP-regulated pharmaceutical setting. The role focuses on ensuring equipment, facilities, utilities, computerised systems, and manufacturing processes meet cGMP and regulatory requirements.

Key Responsibilities
Prepare, review, and approve validation documentation for equipment, facilities, utilities, computerised systems, automation packages, and manufacturing/packaging processes.
Support projects from design through commissioning, qualification, and validation.
Review and approve commissioning and qualification (C&Q;) documentation.
Manage validation deviations, punch list items, and change controls.
Coordinate vendors during commissioning and qualification activities.
Maintain validation schedules and project timelines.
Ensure compliance with cGMP, data integrity, and regulatory requirements.
Promote a robust quality and compliance culture across the site.





Requirements
Bachelor's Degree in Engineering, Science, or a related technical discipline.
5+ years' experience in a pharmaceutical manufacturing setting within Validation, Engineering, or Operations.
Experience with manufacturing and packaging processes, process equipment, facilities, utilities, and control systems.
Strong GMP documentation and technical writing experience.
Experience performing risk assessments and developing risk-based validation protocols.
Knowledge of electronic quality/document management systems such as Kneat, Veeva, and TrackWise.

Key Skills
Validation & Qualification
cGMP Compliance
Change Control
Deviation Management
Risk Assessments
Technical Writing
Vendor Management
Project Planning
Strong Attention to Detail
Stakeholder Management and Communication Skills

📌 Cqv Engineer Dublin (Australia)
🏢 DPS Group Global
📍 Australia