Fred Lewis

WORK HISTORY

EDUCATION

SKILLS

ABOUT FRED LEWIS

As a Project Utilities Engineer for Merck and company, I was the Subject Matter expert for all Critical utilities. I was responsible for troubleshooting difficult performance and quality issues at sites worldwide. I gained this knowledge and experience over 24 years in the pharmaceutical industry, specifically in High Purity Water treatment. I have experience in leading HAZOPs, GMP reviews, FATs, SATs and I have performed risk analysis on these systems.I was responsible for developing standard systems designs, ensuring that the designs were followed in the detailed design phase and provided oversight for fabrication at vendor’s facilities. Although I was functionally assigned to a design group, I was frequently deployed in the field to personally lead start up activities. I have worked in the capacity of Start up lead in Greenfield sites as well as Brownfield. I have simultaneously led multiple startup teams on multiple sites due to the rapid growth in vaccines.I enjoy the energy and excitement of startup activities. I think on my feet and can quickly prioritize activities in order to drive projects. I have frequently provided work around solutions to obstacles that always crop up in a newly constructed facility. I communicate well with people at all levels and vocations. I am equally confortable with breaking down tasks for the trades in order to understand the scope of the job as I am with defending the design features to a quality auditor.Specialties: Critical Utilities; USP purified water, WFI, Clean Steam, Process Air and Noble gassesSubject Matter Expert; High purity water treatment, Distillation, Ion Exchange, Membrane Technology, Ozone and UV irradiation.Experienced in; current Good Manufacturing Practice (cGMP), Good Documentation Practices (GDP), System Life Cycle (SLC), Commissioning and Qualification process.