🛠 Tech Stack

💼 About This Role

You'll lead CQV documentation and protocol execution for pharmaceutical facilities in Australia. Your work directly supports life-saving therapies including COVID-19 vaccines. You'll collaborate with subject matter experts and contribute to cutting-edge projects.

🎯 What You'll Do

• Develop CQV documentation for facilities, utilities, and equipment.
• Write and execute qualification protocols in the field.
• Generate summary reports and manage documentation lifecycle.
• Plan and coordinate work, directing small teams on document development and execution.

📋 Requirements

• BS or MS in relevant science or engineering field, or equivalent experience
• 5–12 years performing CQV activities in FDA regulated industry
• Experience in facilities and equipment startup and troubleshooting
• Knowledge of cGMP and validation protocols (IQ/OQ/PQ)

✨ Nice to Have

• Familiarity with Baseline Guide 5 (Second Edition)
• Experience in biotech, aseptic processing, or gene therapy
• Experience planning/directing C&Q activities

🎁 Benefits & Perks

• 💰 Highly Competitive Salary
• 📚 Continuing Education (internal and external)
• 🔬 Cutting-edge Projects in a highly evolving field