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
Support the maintenance, operation, and repair of all systems, subsystems, and equipment within the client Manufacturing facility.
Ensure all assigned equipment and associated subsystems are maintained in accordance with Federal, State, Local, and Amgen 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
4+ years of experience working with process or utility equipment, preferably in a GMP-regulated pharmaceutical environment due to the documentation requirements.
Versatile using hand and power tools, technical skills include electrical, mechanical, and electromechanical systems, with knowledge of HVAC systems being beneficial.
Familiarity with work order systems is preferred.
The role requires a 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.
Familiarity with machine shop equipment including CNC machine and lathe is a plus
Ability to work safely with 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
Training on Day shift will be approx. 2-3 months (7am - 4pm).
Shift thereafter will be from 4:00PM - 1:00AM Monday - Friday.
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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