CQV Engineer - GMP Validation & Compliance

DPS Group; Leinster; Vor Ort; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Validation & Qualification

cGMP Compliance

Change Control

Deviations Management

Technical Writing

Vendor Management

Project Planning

Risk Assessments

Stakeholder Communication

Quality Systems

Ausbildung

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

Tools

Kneat

Veeva

TrackWise

Jobbeschreibung

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