Validation Engineer

About This Role

Execute IQ/OQ/PQ protocols for critical manufacturing equipment, utilities, and computerized systems. Support process validation and technology transfer activities.

Key Responsibilities

• Develop and execute validation protocols (VMP, IQ, OQ, PQ)
• Coordinate equipment and utility qualification
• Lead computerized system validation (CSV)
• Support process validation (PPQ) for capsule lines
• Manage validation documentation and traceability
• Participate in vendor audits and FAT/SAT
• Ensure 21 CFR Part 11 compliance for all systems

Requirements

• BSc/MSc in Chemical/Mechanical Engineering or Pharmacy
• 4+ years validation experience in pharma manufacturing
• Expert in IQ/OQ/PQ, CSV (GAMP 5), cleaning validation
• Knowledge of EU GMP Annex 15, FDA Guidance
• Experience with MES/LIMS/ERP validation
• Strong documentation and protocol writing skills