Job Description

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:

• Ensure reliable equipment and facility performance by maximizing uptime and enabling integration of new technologies to advance Client's clinical and commercial products supply.
• Maintain and repair all production mechanical equipment
• 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
• 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 filling, freeze drying, and packaging equipment operation, maintenance, and repair
• Full working knowledge of pumps, valves, mechanical seals, motors, and proper lubrication
• Full working knowledge of cGMP and Predictive Maintenance philosophy and techniques
• Ability to create, read, interpret, and revise engineering documents
• Familiarity with machine shop equipment including CNC machine and lathe is a plus
• 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
• Ability to lift up to 50 pounds, climb ladders, and work at elevations up to 15 feet
• Mechanically inclined - person that has experience working with hands/ hands on
• Precision machinery experience highly preferred
• Electro mechanics / electrical background
• GMP background and Cleanroom experience
• Available potentially for 2nd or 3rd shift most likely will be night shift 4 nights on, 3 off.

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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