🛠 Tech Stack

💼 About This Role

You'll lead commissioning, qualification, and validation (CQV) projects for pharmaceutical production facilities in Japan within a 100% employee-owned firm. You'll oversee protocol creation, on-site execution, and team direction to ensure successful project delivery. Join a growing global team that values integrity and collaboration.

🎯 What You'll Do

• Lead on-site CQV documentation execution for production facilities
• Create CQV protocols and prepare summary reports
• Coordinate work plans, manage execution cycles, direct small teams
• Ensure project safety and submit monthly status reports to clients

📋 Requirements

• 15+ years in commissioning, qualification, and validation in FDA-regulated industries
• Project management experience in oral solid dosage pharmaceutical production facilities
• Proficiency in protocol creation and execution (IQ/OQ/PQ, FAT/SAT, etc.)
• Business level Japanese and English proficiency

✨ Nice to Have

• Knowledge of cGMP, PIC/s GMP, EU GMP
• Experience with biotech, aseptic processing, or gene therapy manufacturing
• Bachelor's or Master's in scientific or engineering field

🎁 Benefits & Perks

• 💰 Competitive salary
• 📚 Ongoing education (internal and external)
• 🚀 Cutting-edge projects in a growing field
• 🗺️ Full travel reimbursement for project-related trips
• 🏥 Social insurance coverage