Maintenance Leader

Run With The Best!

 

Located in the famous Bluegrass Region of the United States and known as the "Horse Capital of the World", enjoy the incredible and unique quality of life experienced by those living within the scenic rolling hills of Central Kentucky. 

 

The city of Lexington, Kentucky, located just south of Cincinnati and east of Louisville, is home of champion race horses and Intranasal Therapeutics, Inc (ITI).  ITI is a new premier pharmaceutical company dedicated to the development and commercialization of novel drug products designed to provide an alternative to drug delivery by injection.  ITI is rapidly progressing forward with science and technology developed by the University of Kentucky's School of Pharmacy.  With four (4) Investigational New Drug Applications already filed with the FDA, ITI is preparing for late stage clinical manufacturing to begin in its new state of the art aseptic manufacturing facility.

 

To support our rapid growth, we are currently searching for dynamic individuals to join our dedicated team of professionals.

 

Summary:

 

Responsible for leading the start-up and operation of the maintenance and calibration functions in a pharmaceutical manufacturing facility.

 

?  Perform preventive maintenance, troubleshooting and repair activities for all facility mechanical, electrical and utility systems and manufacturing equipment.

?  Manage the equipment calibration program which includes performing, documenting and reporting calibration activities.

?  Manage the documentation associated with the maintenance program which includes writing and revising SOPs and PM cards, completing work requests and change control documentation.

?  Respond to after hours emergency calls related to plant equipment function.

?  Maintain an adequate inventory of spare parts for emergency and PM work and adhere to cGMPs, SOPs and safety policies.

?  Assist with the design, build, commissioning and validation activities for a major plant expansion.

 

Qualifications:

 

? High School Diploma or equivalent

? HVAC certification or trade school education preferred

? Experience with high-pressure steam boilers

? Experience maintaining or calibrating equipment and utilities such as sterilizers, ovens, USP water systems, HVAC systems, and precision manufacturing equipment in a cGMP regulated environment.

? Good written communication skills to read and write SOPs and complete cGMP documentation.

? Good interpersonal skills and the ability to work well in a team environment.