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 strong 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 environment 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)
🏢 DPS Group Global
📍 Dublin