Senior Equipment Maintenance Specialist

1 week ago


Farmington, Iowa, United States Quality Consulting Group Full time
Job Overview

Quality Consulting Group, a prominent entity in the pharmaceutical, biotechnology, medical devices, and manufacturing sectors, is seeking a dedicated and skilled professional to enhance our operations. This position offers the opportunity to collaborate with a dynamic team in a leading manufacturing environment.

Key Responsibilities:

  • Ensure optimal performance of equipment and facilities by maximizing operational uptime and facilitating the integration of innovative technologies to support clinical and commercial product supply.
  • Conduct maintenance and repairs on all mechanical production equipment.
  • Assist in the maintenance, operation, and repair of systems and equipment within the Fill/Finish facility.
  • Support engineering and operations in the design, installation, testing, and maintenance of Fill Finish manufacturing and support equipment.
  • Maintain compliance with Federal, State, Local, and company regulations, procedures, and policies for all assigned equipment and subsystems.
  • Keep all assigned equipment areas in a state of readiness for inspection.
  • Perform troubleshooting on electrical, pneumatic, and mechanical systems.
  • Complete preventive maintenance tasks and associated documentation in accordance with cGMP guidelines.
  • Coordinate with contractors for repairs, modifications, and installations of equipment.
  • Collaborate with Manufacturing, Engineering, and Quality teams on new system installations or modifications.
  • Participate in all required cGMP and Safety training sessions.
  • Maintain qualifications as required for the role.

Qualifications:

  • Associate degree in a relevant field.
  • Comprehensive knowledge of pharmaceutical filling, freeze drying, and packaging equipment operation, maintenance, and repair.
  • In-depth understanding of pumps, valves, mechanical seals, motors, and lubrication practices.
  • Familiarity with cGMP and Predictive Maintenance principles and techniques.
  • Ability to create, interpret, and modify engineering documentation.
  • Experience with machine shop equipment, including CNC machines and lathes, is advantageous.
  • Capability to safely handle hazardous materials, high and low temperature liquids, high-pressure liquids and gases, steam, varying electrical voltages, and moving machinery.
  • Proficient in reading and understanding P&IDs, following SOPs, and utilizing basic computer skills.
  • Knowledge of Computerized Maintenance Management Systems.
  • Physical ability to lift up to 50 pounds, climb ladders, and work at heights up to 15 feet.
  • Hands-on mechanical aptitude.
  • Experience with precision machinery is highly desirable.
  • Background in electro mechanics or electrical systems.
  • Experience in GMP environments and Cleanroom operations.
  • Availability for potential 2nd or 3rd shifts, primarily night shifts.

Quality Consulting Group, LLC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.



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