Facilities Technician

Maintain manufacturing and facility

Maintain manufacturing and facility areas in accordance with FDA inspection standards.

Essential Duties And Responsibilities

• Maintain areas of the facility in a state of FDA inspection
• Complete annual, monthly, weekly and daily maintenance and calibration
• Perform equipment and facility maintenance
• Perform limited equipment troubleshooting and support the resolution of Quality issues
• Afford support to the change management system for validated equipment, utilities and services
• Support the change management system for validated equipment, utilities and services
• Perform other duties as assigned

Education and/or Experience

• High School diploma, GED, or construction trade school required
• Experience in diagnosing and repairing a wide variety of mechanical, electrical, and pneumatic equipment problems
• Minimum 2 years of experience in a similar role in a cGMP manufacturing plant

Qualifications

• Reasonable accommodations may be made to enable individuals with disabilities to perform the described functions
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
• Ability to write notes, documentation, routine reports and correspondence
• Ability to complete forms accurately
• Ability to effectively communicate information in one-on-one and small group situations to customers, clients, and other employees of the organization
• Ability to add, subtract, multiply, and divide and ability to perform these operations using units of American money and weight measurement, volume, and distance
• Technological proficiency for use of the personal computer, Microsoft Office Suite, and the Internet

Desired Knowledge, Skills, And Abilities

• Understanding of facilities and utilities
• Knowledge of building management systems (such as; Siemens, Johnson Controls, )
• Strong understanding of cGMP’s and GMP
• Knowledge to operate CMMS software (such as; BMRAM, Maximo, etc.)
• Ability to work in an environment with little or no distractions
• Ability to practice and demonstrate thorough awareness of applicable mechanical, electrical, and biological safety guidelines and standards
• Ability to diagnose and repair a wide variety of mechanical, electrical, and pneumatic equipment
• Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions
• Ability to clearly document maintenance
• Demonstrated ability in oral and written communication
• Ability to interface with many levels of employees of various disciplines within various departments
• Ability to type or use a keyboard
• Ability to coordinate and synchronize multiple tasks
• Ability to function in a controlled environment regulated by FDA
• Ability to handle confidential information

Physical Demands and Work Environment

• The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel with fine dexterity, occasionally required to use a firm grasp; push/pull and talk or hear.
• The employee is frequently required to stand; walk; sit; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl.
• The employee must regularly lift and /or move up to 50 pounds.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus (with corrective lenses, if needed).
• The noise level in the work environment is usually somewhat quiet to moderate.