QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

• Maintain and repair all production mechanical equipment

• Perform Maintenance and troubleshooting on process and utility equipment.

• Work with building client in Utilities, Warehouse and Packaging areas.

• Support the maintenance, operation, and repair of all systems, subsystems, and equipment within the clients Fill / Finish facility

• Provide support to engineering and operations in the design, installation, testing, operation, and maintenance of Fill Finish manufacturing and support equipment

• Ensure all assigned equipment and associated subsystems are maintained in accordance with Federal, State, Local, and client's regulations, procedures, and policies

• Maintain all assigned equipment areas in a constant state of inspection readiness

• Identify training deficiencies and provide recommendations and training where applicable

• Continuously evaluate and improve maintenance practices and documentation

• Perform troubleshooting of electrical, pneumatic, and mechanical equipment

• Complete preventive maintenance and assigned paperwork following all cGMP documentation guidelines

• Coordinate contractors for repairs, modifications, and installations of equipment

• Work directly with Manufacturing, Engineering, and Quality organizations on new system installations or modifications

• Attend all required cGMP and Safety training

• Maintain qualifications as assigned

Qualifications:

• Associate degree in related area

• Thorough working knowledge of pharmaceutical packaging equipment operations, maintenance, and repair

• Full working knowledge of pumps, valves, mechanical seals, motors, and proper lubrication

• 10 years of experience working with process or utility equipment, preferably in a GMP-regulated pharmaceutical environment due to the documentation requirements.

• Possess strong technical skills, particularly in electrical, mechanical, and electromechanical systems, with knowledge of HVAC systems being beneficial.

• Familiarity with work order systems is preferred. 

• Self-sufficient individual who can work independently, especially during after-hours shifts, and is comfortable with rotating on-call duties.

• Excellent communication skills and the ability to work within the GMP framework are essential, and while pharmaceutical experience is preferred, candidates from related fields are considered if they are open to learning GMP practices.

• Ability to work safely with hazardous chemicals, high and low temperature liquids, high pressure liquids and gasses, steam, varying electrical voltages, and moving machinery

• Ability to read and understand P&IDs, work from SOPs, and use basic computer skills

• Knowledge of and ability to use Computerized Maintenance Management Systems

• Familiarity with machine shop equipment including CNC machine and lathe is a plus

• Training on Day shift will be until Jan/Feb; then in late January / early February the shift will be from 4:00PM - 1:00AM Monday - Friday. It will most likely last until December 2025 and beyond.

• Capable of multi-tasking and working overtime or temporarily modifying shift schedule as needed. (Must be flexible with schedule)

  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.

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