Senior GMP CQV Validation Engineer

DPS Group Global; Leinster; In loco; EUR 70.000 - 100.000; Tempo pieno

Descrizione del lavoro

DPS Group Global 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.

Responsibilities include preparing and approving validation documentation, managing deviations, change controls and coordinating vendors, while maintaining schedules

Competenze

• Bachelor's degree in engineering, science, or related technical field.
• 5+ years' experience in pharmaceutical manufacturing in Validation, Engineering, or Operations.
• Experience with manufacturing/packaging processes, process equipment, facilities, utilities and control systems.
• GMP documentation and technical writing experience.
• Experience performing risk assessments and developing risk-based validation protocols.
• Knowledge of electronic quality and document management systems (Kneat, Veeva, TrackWise).

Mansioni

• 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.

Conoscenze

Validation & Qualification

cGMP Compliance

Change Control

Deviation Management

Risk Assessments

Technical Writing

Vendor Management

Project Planning

Attention to Detail

Stakeholder Management

Formazione

Bachelor's Degree in Engineering, Science, or related

Strumenti

Kneat

Veeva

TrackWise

Descrizione del lavoro

DPS Group Global 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.

Responsibilities include preparing and approving validation documentation, managing deviations, change controls and coordinating vendors, while maintaining schedules