Senior Validation Engineer in Athens

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Job Description

We’re seeking an experienced Validation professional to independently lead and execute complex validation activities supporting GMP manufacturing operations. This role is ideal for a hands-on, compliance-focused expert who can balance multiple priorities, lead validation efforts with minimal oversight, and partner cross-functionally to support equipment readiness, inspections, and new product launches.

Key Responsibilities

Validation Leadership & Execution

• Independently draft, execute, and close validation plans, protocols, test strategies, and final reports
• Lead qualification activities for equipment, facilities, utilities, and computerized systems
• Serve as Lead Validation representative on project teams supporting changes, deviations, tech transfers, and new product launches
• Ensure validation activities meet GMP, FDA, EU, and internal quality requirements
• Maintain validation areas in a constant state of inspection readiness

Technical & Cross-Functional Support

• Partner with Engineering, Maintenance, Production, and Quality teams on system selection, upgrades, and commissioning
• Develop and review URS, RA, FRS, and DQ documentation
• Support cleaning validation, utilities qualification (HVAC, water, gases), and media fill oversight
• Execute requalification and periodic reviews for autoclaves, depyrogenation tunnels, cold rooms, freezers, and warehouse areas
• Perform room qualifications and smoke studies in Grade A pharmaceutical environments

Compliance, Audits & Continuous Improvement

• Support Change Controls, Deviations, and CAPAs, ensuring on-time closure
• Assist with audit responses and regulatory inspections
• Train personnel on validation and quality principles
• Monitor and support completion of required compliance training and KPIs

Required Experience

• 6+ years of GMP validation experience in a regulated manufacturing environment
• (10+ years accepted in lieu of a degree)
• At least 3 years leading validation projects
• Strong experience with:
• Equipment, facilities, utilities, and computer system validation
• Cleaning validation concepts
• Pharma-grade utilities (HVAC, water, gases)
• Ellab data loggers and software
• Extensive technical writing experience with minimal reviewer oversight
• Ability to analyze validation and production data to assess GMP compliance
• Strong leadership, planning, and cross-functional collaboration skills
• Excellent written and verbal communication skills
• Proficiency with MS Word, Excel, Outlook, and PowerPoint

Education

• Bachelor’s degree (Science or Engineering discipline)

Why This Role

• High-visibility validation ownership with real operational impact
• Opportunity to lead complex projects in a regulated biopharmaceutical environment
• Strong cross-functional exposure across Engineering, Production, and Quality

If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.