Engineering Leadership & GMP Excellence

Louay K. Ghonaym is an accomplished Director of Engineering & Facilities and Senior Chemical Process Engineer with 20+ years of experience in pharmaceutical, chemical, and medical device manufacturing. He specializes in the full lifecycle of GMP facility design, HVAC and critical pharmaceutical utilities (Sterile Water for Injection, Clean Steam, Deionized Water), cleanroom construction, equipment validation, and compliant operations.

As the founder of Ghonaym Biotech and Engineering of Houston LLC, Louay leads integrated delivery across cleanroom design & CQV, process engineering, HVAC/electrical systems, and calibration & metrology. His approach blends craft and compliance, aligning every project with ASHRAE, ISO 14644, and GMP best practices.

Selected Achievements

• Directed multimillion-dollar capital projects in sterile and radiopharma manufacturing.
• Led end-to-end design, commissioning, and validation of Clean Rooms suites and automated fill lines.
• Established and managed Engineering & Facilities functions (HVAC, utilities, calibration, automation).
• Implemented VHP sterilization cycles, CIP/SIP, and risk-based validation to optimize uptime.
• Applied Lean/Six Sigma to increase capacity, reliability, and compliance across multiple sites.

Core Experience

Education

University of Utah — B.S. Chemical Engineering; B.S. Professional Chemistry. Languages: English, Arabic.