CQV Engineer

DPS Group; Leinster; On-site; EUR 70,000 - 100,000; Full time

Job summary

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

You will prepare, review and approve validation documentation for equipment and processes, manage deviations and change controls, and coordinate with vendors to

Qualifications

• Bachelor's degree in engineering, science or related technical discipline.
• 5+ years' experience in pharmaceutical manufacturing focused on Validation, Engineering or Operations.
• Experience with manufacturing/packaging processes, process equipment, facilities, utilities and controls.
• Strong GMP documentation and technical writing experience.
• Experience with risk assessments and risk-based validation protocols.
• Knowledge of electronic quality/document management systems such as Kneat, Veeva and TrackWise.

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.

Skills

Validation & Qualification

cGMP Compliance

Change Control

Deviations Management

Technical Writing

Vendor Management

Project Planning

Risk Assessments

Stakeholder Communication

Quality Systems

Education

Bachelor's Degree in Engineering, Science, or a related technical discipline

Tools

Kneat

Veeva

TrackWise

Job description

Overview

We are seeking an experienced Validation Engineer to support commissioning, qualification, and validation activities within a GMP-regulated pharmaceutical environment. 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