With over 30 years of experience in the field, I specialize in taking projects from concept to delivery for unrestricted operation, based on customer-generated critical quality attributes. I can design or provide quality reviews of facilities, including HVAC, BAS, BMS, and room construction. Additionally, I offer expertise in utilities, equipment, data acquisition control systems, and the requisite databases and reporting systems. My extensive experience includes over 20 years in CSV and DI program development. I am dedicated to ensuring the highest standards of quality and compliance for your business.

2020 to Current: Site Data Integrity Manager.

2000 to 2020: Site Computerized System Validation Expert Transitioning to Data Integrity in 2015 upon release of 2015 MHRA guidance. 

Since 1995: Writing and executing Facility and Equipment Commissioning and Qualification documentation. Equipment includes, but is not limited to:

• Facilities
• HVAC
• Building Management Systems (BMS)
• Environmental Monitoring Systems (EMS)
• USP Purified Water Systems
• Compressed air and nitrogen
• Glatt Air Techniques (GAT) Fluid Beds
• Vertical Granulators
• Lyophilizer
• Tablet Press
• Capsule Filler
• Capsule Check Weigher
• Stick Pack
• Bottling, Packaging
• Mills: Granu, Bead, Hammer, etc