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Senior Equipment Maintenance Specialist

2 months 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 operational capabilities. This position involves collaborating with a dynamic team in a world-class manufacturing environment.

Key Responsibilities:

  • Optimize equipment and facility performance to ensure maximum uptime and facilitate the integration of innovative technologies that 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 equipment.
  • Ensure compliance with Federal, State, Local, and company regulations, procedures, and policies for all assigned equipment.
  • Maintain equipment areas in a state of readiness for inspections.
  • Troubleshoot electrical, pneumatic, and mechanical systems effectively.
  • Execute preventive maintenance tasks and complete necessary documentation in accordance with cGMP guidelines.
  • Coordinate with contractors for repairs, modifications, and installations.
  • Collaborate with Manufacturing, Engineering, and Quality teams on new system installations or modifications.
  • Participate in required cGMP and Safety training sessions.
  • Maintain required qualifications as designated.

Qualifications:

  • Associate degree in a relevant field.
  • Comprehensive knowledge of pharmaceutical filling, freeze drying, and packaging equipment operations and maintenance.
  • Proficient understanding of pumps, valves, mechanical seals, motors, and lubrication practices.
  • Solid grasp of cGMP and Predictive Maintenance principles and techniques.
  • Ability to create, interpret, and modify engineering documentation.
  • Familiarity with machine shop tools, including CNC machines and lathes, is advantageous.
  • Capable of safely handling hazardous materials and operating under various conditions.
  • Ability to read and understand P&IDs, follow SOPs, and utilize basic computer skills.
  • Experience with Computerized Maintenance Management Systems.
  • Physical capability to lift up to 50 pounds, climb ladders, and work at heights.
  • Hands-on mechanical aptitude with a background in precision machinery preferred.
  • Electromechanical experience is a plus.
  • Knowledge of GMP standards and Cleanroom protocols.
  • Willingness to work flexible shifts, including potential night shifts.

Quality Consulting Group, LLC is an equal opportunity employer, and 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.