Validation Engineer

Qualification: Diploma or BE in Mechanical Engineering

Key Responsibilities

• Experience in pharma packaging machines, including:
• Tablet counting and filling lines
• Liquid filling lines
• Standalone machines (Cartoning, Tablet Printing, Tube Filling, Labelling, Check Weigher, Capping, Induction Sealing)
• Ability to read Machine GA, Layout, Pneumatic & Electrical drawings
• Knowledge of:
• cGMP compliance and GEP standards
• 21 CFR Part 11 compliance
• Documentation:
• Preparation of IQ, OQ, DQ, PQ, FS documents, service manuals, QA checklists
• Coordination with Purchase for Test and MOC certificates
• Awareness of interlocks and logical testing procedures
• Conduct IFAT and CFAT, share open points with production
• Ensure compliance and prepare reports for dispatch clearance
• Handle ISO audits and maintain required reports
• Support validation and documentation as per dispatch and validation plan
• Site visits or regional support for qualification if needed
• Communicate effectively with export customers and outsourced vendors