🛠 Tech Stack

💼 About This Role

You'll support the Commercial Manufacturing Facility by reviewing and approving qualification/validation activities for facilities, utilities, equipment, and systems. You'll ensure compliance with regulations like 21 CFR Part 11 and GAMP 5, while driving process improvement initiatives.

🎯 What You'll Do

• Generate risk assessments, URS, C&Q plans, and change controls
• Support validation lifecycle activities including periodic reviews
• Make compliance decisions to support commercial operations
• Provide support during client and regulatory audits

📋 Requirements

• Bachelor's degree in science or engineering
• Minimum 4 years experience in pharmaceutical industry
• Minimum 4 years performing qualifications/validations

✨ Nice to Have

• Experience in Oral Solid Dose operations and spray drying
• 5-10 years of pharmaceutical industry experience