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: Operate assigned equipment, facility, utility, and HVAC Systems in accordance with established guidelines and operating procedures.
Conduct basic troubleshooting and employ basic predictive technologies to identify root cause and appropriate corrective actions for equipment problems or to diagnose equipment problems.
Perform intermediate troubleshooting of utility, process, and HVAC related equipment/ systems.
Review utility, process system/equipment, Plumbing, ductwork plans, architectural, and HVAC P&ID.
Assist the team with maintaining an up-to-date working spare parts inventory system for the equipment/systems the team is responsible for.
Perform various ""Housekeeping"" activities, (i.e., keeping work areas clean, cleaning of equipment etc.).
Ensure that operational log paperwork, daily log files, and work order documentation is completed with accurate information.
Provide detailed training program in order to develop one's knowledge in the maintenance and operations field and other areas of the plant.
All work must be completed in accordance with CFRs, cGMPs, SOPs, job plans, and Amgen policies.
Develop, revise, and review related SOPs or job plans/work plans for work related areas.9.
Assist in the evaluation of the current maintenance procedures and recommend changes to optimize the maintenance program.
Perform intermediate troubleshooting of utility, process, and HVAC related equipment/ systems.
Plan and schedule own work activities with operations staff to minimize impact to production activities.
Qualifications: Associate degree Two (2) years of Maintenance experience Technical knowledge and experience working with Manufacturing Equipment Operations and Maintenance, Process Equipment and System Maintenance, CIP/SIP Operations.
Experience working in a GMP environment.
Knowledge of electrical systems including different types of sensors or electronic units, and low voltage systems.
Knowledge and experience working and troubleshooting with electrical and/or mechanical units.
Ability to read and understand schematics.
Experience with Vial/Syringe aseptic filling equipment and cleaning processes or machines like Parts Washers, Ultrasonic Washer, Autoclave, among others.
Knowledge and experience in debagger, Isolator, ebeam, Filler machine, robots, conveyors, aseptic techniques.
Experience with set up alignment tools.
Good Communication Skills both verbal and written.
Knowledge and ability working with Microsoft office (word, excel, power point) and other computer applications.
Availability for 12 hour shift (5:00 pm - 5:30 am) (Week 1: Mon, Thu, Fri; Week 2: Tue, Wed, Sat, Sun) 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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