SUMMARY:
Under general supervision, execute intermediate maintenance activities. 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.
FUNCTIONS:
- Execute intermediate maintenance activities, or operates and monitors plant support equipment, referring complex issues or problems to more experienced personnel.
- 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 ones 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.
- Maintain an up-to-date cGMP training book.
- Develop, revise, and review related SOPs or job plans/work plans for work related areas.
- 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.
- Provide basic support of start-up of new equipment to ensure it meets all mechanical design specifications.
- Review utility, process system/equipment, Plumbing, ductwork plans, architectural, and HVAC ID
- Support on-call response by maintaining a pager or cell phone while on-call.
- Develop a basic proficiency in one or more advanced maintenance technology and understand how to apply technology to improve equipment reliability (alignment, balancing, thermography, oil analysis, ultrasound, electric motor circuit analysis, metrology or vibration monitoring).
** Other functions that may be assigned**
EDUCATION:
- Associate’s degree or High school/GED + 1 year of maintenance work or military experience.
PREFERRED QUALIFICATIONS
- 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, E-beam, 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.
Specific responsibilities include but are not limited to:
- Perform basic maintenance, troubleshooting and repair tasks to Manufacturing equipment such as Vial and syringe filler, Nested syringe and Adaptive Line, autoclaves, parts washers, portable tanks and another manufacturing equipment or system including process control and laboratory instruments.
- Provide basic support of start-up of new equipment to ensure it meets all mechanical design specifications.
- Perform regular certification of equipment to verify conformance to industry standards and Amgen procedures.
- Support the team with maintaining an up-to-date working spare parts inventory system.
- Perform daily tasks following SOPs or job plans/work plans for work related areas.
- Support the team in optimizing the maintenance program by identifying improvement opportunities and recommend changes to existing maintenance procedures.
WORK METHODOLOGY:
- Full on site job in Juncos, PR
- Full time job
- Expected project duration: 14 months for the first contract, with a high possibility of extension based on performance and budget.
- 12 hour shift (5:00pm - 5:30am). Weekends and overtime may also be required.
- Expected hiring date: March 2026