Senior CQV Engineer - GMP Validation & Compliance

DPS Group Global

South Dublin

On-site

EUR 65,000 - 95,000

Full time

23 hours ago
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Job summary

DPS Group Global is seeking an experienced Validation Engineer to support commissioning, qualification and validation activities within a GMP-regulated pharmaceutical environment in Ireland. The role focuses on ensuring equipment, facilities, utilities and computerised systems meet cGMP and regulatory requirements, while leading risk-based validation, change control and deviation management.

You will collaborate with project teams to review documentation and ensure timelines and data integrity

Qualifications

  • 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.

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
Deviation Management
Technical Writing
Project Planning
Attention to Detail
Stakeholder Management

Education

Bachelor's degree in Engineering/Science or related

Tools

Kneat
Veeva
TrackWise

Job description

DPS Group Global is seeking an experienced Validation Engineer to support commissioning, qualification and validation activities within a GMP-regulated pharmaceutical environment in Ireland. The role focuses on ensuring equipment, facilities, utilities and computerised systems meet cGMP and regulatory requirements, while leading risk-based validation, change control and deviation management.

You will collaborate with project teams to review documentation and ensure timelines and data integrity

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