Retired
Mechanical Engineer, Senior Specialist Quality Assurance
An enthusiastic and experienced Chartered Engineer with 25+ years in the International Pharmaceutical industry, specializing in engineering and quality roles.
• Led a 3-person team in developing and implementing Amgen’s science and risk-based equipment qualification process.
• Co-led the second edition of the ISPE Baseline Guide for Commissioning and Qualification.
• Subject matter expert in critical utility and HVAC systems.
• Managed high-performance teams responsible for commissioning and qualification activities.
• Developed and implemented company-wide Good Engineering Practice (GEP) Procedures.
• Acted as the quality representative overseeing the qualification of controlled temperature shipping systems and distribution QMS.
• Active ISPE member for 22 years, contributing to multiple guides and co-leading the Science and Risk-Based C&Q Guide.