Summary:

Direct and organize all maintenance and engineering activities in the Compounding Department.  Perform preventative maintenance on equipment.  Troubleshoot and repair malfunctioning equipment.  Drive and participate in continuous improvement initiatives within the department.

 

Essential Duties and Responsibilities:

• Behavior: Exhibit team player qualities of cooperation and coordination; professional interaction in all business contacts, all day, every day


• Attendance: Present for work when scheduled is a mandatory function.


• Safety: Comply with all requirements of the safety program, including adherence to all safety rules.  Reporting of safety issues is mandatory.


• Ensure the department’s compliance with ATF, FDA, OSHA, and other regulatory policies. Develop and implement procedures that follow all regulatory agency requirements.


• Support and maintain Compounding processes and equipment.


• Development of a preventative maintenance plan for Compounding equipment. Performing preventative maintenance on Compounding equipment.


• Troubleshooting and repair of malfunctioning Compounding equipment.


• Procedure development for Lock-out/Tag-out of new and modified equipment.


• Overseeing the installation of and testing out engineering improvement projects.


• Specifying, ordering, and organizing spare parts for equipment.


• Develop and implement an organized training program for all compounding personnel in the technical aspects involved with the operation of equipment. This training includes new personnel and upgrades for more experienced personnel.


• Analyze current equipment and processes, recommend and implement approved modifications necessary to improve equipment reliability, product quality, reduce cost, streamline the manufacturing process and optimize utilization of personnel and other resources.


• Plan, direct, and work closely with Research and Development in the implementation of new products or processes. Transfer knowledge obtained to all department employees.


• Create and maintain an atmosphere that encourages continues improvement and team based problem solving.


• Direct and assist in conducting root cause analysis. Develop corrective action training programs as a result of root cause analysis.


• Communicate with company personnel on projects, priorities, timetable and budgets, as necessary.

 

Supervisory Responsibilities:

None

 

Competencies:

• High degree of demonstrated problem solving ability. 


• Must have thorough understanding of manufacturing practices, including GMP and FDA regulations. 


• Excellent written and verbal communication skills required.


• Ability to read engineering drawings. 


• Familiarity with Lock-out/Tag-out procedures.


• Pumps, valves, mixers, scales, meters, hoist, computer and related software packages, other standard office equipment.

 

Certificates, Licenses, Registrations:

None

 

Travel:

Limited

 

Work Environment:

Worker exposed to typical production plant conditions, including some inside and outside conditions.  Worker exposed to sufficient noise to cause worker to shout in order to be heard above the ambient noise level.   Worker occasionally exposed to some atmospheric conditions.

 

Physical Demands:

Walking, climbing, balancing, stooping, reaching, grasping, feeling, hearing, kneeling, pushing, sitting, talking. Heavy physical work.  Employee required exerting up to 50 pounds of force occasionally, and/or up to 20 pounds of force frequently.  Employee required to lift 50 pounds or more occasionally. Clarity of vision at 20 inches or less, with the ability to distinguish colors and adjust eye to bring objects into sharper focus.