🛠 Tech Stack

💼 About This Role

You'll lead commissioning, qualification, and validation of GMP facility systems in a biopharma environment. Your work ensures safe, compliant, and inspection-ready operations for life-enhancing therapies.

🎯 What You'll Do

• Lead CQV activities for HVAC, utilities, and GMP infrastructure.
• Develop and approve validation lifecycle documentation (URS, IQ, OQ, PQ).
• Oversee operation, maintenance, and reliability of facility systems.
• Manage corrective and preventative maintenance programs.

📋 Requirements

• Bachelor's degree in Engineering (Mechanical, Chemical, Electrical preferred).
• 5–10 years of CQV or facilities engineering in GMP environment.
• Strong experience with GMP utilities and cleanroom systems.
• Knowledge of FDA/EMA regulations and validation principles.

✨ Nice to Have

• CAPEX project experience.
• Familiarity with ISPE guidance and ASTM E2500.
• Experience with BMS/EMS systems.

🎁 Benefits & Perks

• 🏖️ Flexible PTO
• 🏥 Health insurance
• 📈 Career growth opportunities
• 🎓 Learning support

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Technical Interview· 60 min
3. 3Offer· 30 min