Packaging Validation Engineer

Responsibilities :

• Lead the packaging validation project, coordinating cross-functional efforts and ensuring alignment with project objectives, timelines, and regulatory requirements.
• Develop and execute validation documentation (URS, risk assessments, FAT / SAT, IQ / OQ / PQ, and final reports) for packaging lines and related equipment, including fillers, cappers, labellers, conveyors, vision inspection, and serialization systems.
• Manage communication between validation, engineering, and quality teams to drive efficient decision-making and issue resolution.
• Oversee qualification of change parts, line configuration changes, and multiple bottle / cap presentations.
• Provide hands-on support during commissioning and execution phases, including troubleshooting and deviation resolution.
• Support process performance qualification (PPQ) activities and readiness for commercial production.
• Ensure all validation deliverables comply with cGMP, FDA, and EU Annex 1 requirements, as well as internal procedures and the site's Validation Master Plan (VMP).

Requirements :