CQV Engineer

DPS Group Global

South Dublin

On-site

EUR 80,000 - 110,000

Full time

10 days ago

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Job summary

DPS Group Global is seeking an experienced Validation Engineer to support commissioning, qualification, and validation activities in 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 and review validation documentation, manage deviations and change controls, and coordinate quality-driven validation activities across projects to

Qualifications

  • Bachelor’s degree in engineering/science or related field.
  • 5+ years in pharma manufacturing, Validation, Engineering or Operations.
  • Experience with GMP documentation and risk-based validation.

Responsibilities

  • Prepare, review, and approve validation docs for equipment, facilities, utilities, and systems.
  • Support projects from design through commissioning, qualification, and validation.
  • Review and approve C&Q documentation.
  • Manage deviations, punch lists, 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 on site.

Skills

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

Education

Bachelor's Degree in Engineering, Science, or 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
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