Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. 

Responsibilities:

1. Execute intermediate maintenance activities, or operates and monitors plant support equipment, referring complex issues or problems to more experienced personnel

.2 Assist the team with maintaining an up-to-date working spare parts inventory system for the equipment/systems the team is responsible for

3. Perform various ""Housekeeping"" activities, (i.e., keeping work areas clean, cleaning of equipment etc.).

4. Ensure that operational log paperwork, daily log files, and work order documentation is completed with accurate information.

5. Provide detailed training program in order to develop one's knowledge in the maintenance and operations field and other areas of the plant.

6. All work must be completed in accordance with CFRs, cGMPs, SOPs, job plans, and Amgen policies.

7. Maintain an up-to-date cGMP training book.

8. 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.

10. Perform intermediate troubleshooting of utility, process, and HVAC related equipment/ systems.

11. Plan and schedule own work activities with operations staff to minimize impact to production activities.

12. Provide basic support of start-up of new equipment to ensure it meets all mechanical design specifications.

13. Review utility, process system/equipment, Plumbing, ductwork plans, architectural, and HVAC P&IDs.

14. Support on-call response by maintaining a pager or cell phone while on-call.

15. 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

Qualifications Requirements/Knowledge/Education:

• Associate’s degree and 2 years of Maintenance experience OR

High School diploma/GED and 4 years of Maintenance experience

Skills: 

• 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.

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.

Mentor Technical Group 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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