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