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Pharmaceutical Validation

Qualified Building Management System for Pharmaceutical and Medical Research Company

Owner Requirements

EES pharmaceutical validation

Eli Lilly, a world class pharmaceutical and medical research company, needed a control system integrator for their new modular facility. The facility needed a Qualified Building Management System (QBMS) as required by the FDA. An important aspect of this project was speed: the product needed to be able to hit the market quickly.


They required a unique skill set that included PLC, HMI, mechanical design, commissioning, and validation expertise. Due to the nature of of Eli Lilly’s highly-regulated drug/medicine manufacturing, they needed a partner with experience in pharmaceutical facilities systems integration requirements and most importantly, extensive experience in HVAC design and installation.


Under EES’ scope were 17 air handlers with associated instrumentation. EES was responsible for:

  • Acting as liaison between Pharmadule and Rockwell Automation
  • Reviewing FRS & Design Documentation (refer to Section
  • Coordinating the system start-up team
  • Providing input to functional test protocols
  • Assisting in executing Functional Test Protocols


The building was designed by Pharmadule, a Swedish company that uses a modular design. The building was built in sections the size of a cargo container, complete with all finish and internal mechanical and electrical components, shipped to the USA and assembled onsite. EES participated in virtual fly-thru’s during design and went to Gutenburg Sweden to inspect the construction. This method took 9 months off the construction schedule.



Engineered Energy Solutions (EES) was directed by Eli Lilly to provide technical and operational supervision over all suppliers, engineers, and project personnel involved in the environmental controls for the new facility. The responsibility to put all parts of the working puzzle together fell to Bruce Marson, at the time EES’ Production Manager (now President and CEO).


The scope of EES’ assignment for Eli Lilly included implementation of Lilly’s commissioning and qualification standards to the HVAC systems within the new modular facility. One of the attributes of the implementation of the modular facility design was speed to market. As a result, EES’ overall HVAC experience filled the gaps and mitigated project risk. Along with their supervisory duties, Engineered Energy Systems’ major responsibility was to support PLC and HMI software development, define trade personnel areas of responsibility, and to coordinate these activities with the commissioning and validation teams involved in the project.



Eli Lilly’s precedent setting modular manufacturing facility, launched in April of 2004, is projected to be fully operational by November 2006. Learn about the facility that is still in production, now more than 15 years later.