CQV Engineer

🧪 CQV Engineer | Commissioning, Qualification & Validation

📍 [Location – Los Angeles, CA]

🕒 Onsite

Duration - 12 months contract

Intellectt Inc is looking for a highly motivated CQV Engineer to join our team supporting key projects in the pharmaceutical and biotech sector. In this role, you’ll be responsible for ensuring that equipment, utilities, and systems are properly commissioned, qualified, and validated in accordance with GMP regulations and project requirements.

This is a great opportunity to work on cutting-edge projects in a dynamic and growing organization committed to quality, innovation, and compliance.

🔧 What You’ll Do:

• Develop and execute IQ/OQ/PQ protocols for equipment, utilities, and systems.
• Lead and support commissioning activities, system walk-downs, and FAT/SAT execution.
• Ensure all systems meet GMP, FDA, EMA, and industry standards.
• Collaborate across engineering, QA, manufacturing, and vendors to drive successful project execution.
• Maintain validation documentation and support deviation management, CAPAs, and change control processes.
• Work in compliance with ASTM E2500, ISPE Baseline Guides, and internal procedures.

🎯 What We’re Looking For:

• Bachelor’s Degree in Engineering (Chemical, Mechanical, Biomedical) or Life Sciences.
• 2–5 years of CQV experience in a regulated pharma/biotech environment.
• Solid knowledge of GMP, cGMP, and risk-based validation approaches.
• Strong experience with equipment qualification, clean utilities, and/or process systems.
• Excellent technical writing and communication skills.
• Self-motivated, detail-oriented, and team-focused.