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Maintenance Technician (GMP Environment)
Maintenance Technician (GMP Environment)Mentor Technical Group • West Columbia, SC, US
Maintenance Technician (GMP Environment)

Maintenance Technician (GMP Environment)

Mentor Technical Group • West Columbia, SC, US
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Job Description

Job Description

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, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets : United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Responsibilities :

  • 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.
  • 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 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.
  • 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 P&ID? s.
  • 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).

Qualifications Requirements / Knowledge / Education / Skills :

  • Associate degree and 2 years of Maintenance experience OR High School diploma / GED and 4 years of Maintenance experience.
  • Ability to effectively communicate ideas through verbal and written form.
  • Intermediate computer skills.
  • Ability to interact constructively with peers / teams.
  • Ability to seek outside resources as needed.
  • Knowledgeable of one or more of the following technical areas : Utility Plant Operations / Maintenance, Process Equipment / System Maintenance, HVAC Operations / Maintenance, or Fire System. Maintenance Technician Competencies.
  • HVAC / Certification Technician Competencies :  HVAC Balancing, Air Handler maintenance & troubleshooting. Building Management System Operational Knowledge. Familiarity with basic Cleanroom, Fume Hood, Biological Safety Cabinet, and Unidirectional Flow Hood systems.
  • Fire Systems Technician Competencies : Knowledge of various fire detection, fire prevention, and fire suppression systems and their maintenance. Knowledge of low-voltage electrical systems. Operational knowledge of fire control panels (FACP) and ability to perform simple troubleshooting. Ability to read and understand schematics and job blueprints.
  • Process Maintenance Technician Competencies :  Route Cause Analysis, Reliability Centered Maintenance, Preventative Maintenance and Troubleshooting experience with miscellaneous production equipment (Tanks, pumps, Chrom / UF Skids, Columns, CIP, COP, Autoclaves, Glass Washers, Lyophilizes, Ovens, Tunnel Washers, Bedding Dispensers, Cage Washers, etc.). Rotating equipment balancing and aligning knowledge. Machine Shop and welding experience. Utility Plant Technician
  • Competencies : Central Utility Plant Operational, Maintenance, and Troubleshooting knowledge of miscellaneous equipment (WFI Still, Clean Steam Generator, Purified Production Units, Water Distribution Systems, Water Softeners, Chillers, Boilers, Cooling Towers, Neutralization Systems, Emergency Power Systems, and UPS.
  • Physical Requirements and Working Environment :

  • While performing the duties of this job, the employee is regularly required to use hands to finger, handle, feel, or operate equipment, tools, or controls. The employee frequently is required to stand, walk, talk, or hear; sit; climb or balance, stoop, kneel, crouch or crawl; and smell. The employee may lift and / or move up to 25-35 pounds and occasionally lift and / or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and the ability to adjust focus.
  • He / she may frequently work inside weather conditions, near moving mechanical parts, exposed to wet and or humid conditions, and an odorous atmosphere, may be exposed to fumes and the risk of electrical shock, and occasionally work on ladders in high places, in small spaces, such as lift / metering stations, manholes, tanks and wet wells. The noise level in the work environment is usually moderately loud.
  • 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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    Maintenance Technician • West Columbia, SC, US

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