Senior CQV Engineer — GMP Validation & Compliance

DPS Group Global; Dublin; Sur place; AUD 110 000 - 150 000; Plein temps

Résumé du poste

DPS Group Global is seeking an experienced Validation Engineer to support commissioning, qualification, and validation activities in a GMP-regulated pharmaceutical environment. You will ensure equipment, facilities, utilities, and computerised systems meet cGMP and regulatory requirements.

Responsibilities include preparing validation documentation, leading projects from design to validation, and coordinating with vendors while maintaining schedules.

Qualifications

• Bachelor's Degree in Engineering, Science, or 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.

Responsabilités

• 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.

Connaissances

Validation & Qualification

cGMP Compliance

Change Control

Deviation Management

Risk Assessments

Technical Writing

Vendor Management

Project Planning

Attention to Detail

Stakeholder Management & Communication

Formation

Bachelor's degree in Engineering, Science, or related technical discipline

Description du poste

DPS Group Global is seeking an experienced Validation Engineer to support commissioning, qualification, and validation activities in a GMP-regulated pharmaceutical environment. You will ensure equipment, facilities, utilities, and computerised systems meet cGMP and regulatory requirements.

Responsibilities include preparing validation documentation, leading projects from design to validation, and coordinating with vendors while maintaining schedules.