Position Purpose:
The Facility technician role is responsible for maintenance and safekeeping of all facilities, equipment, and other vital tools used by the company for production. This position will be responsible for providing engineering and technical support to the facility of uBriGene. The Facility Specialist will work with the manufacturing, quality and GMP/PD teams to develop and maintain the facility and equipment in a state of control for cGMP manufacturing. This position also supports validation activities to complete ongoing facility qualification/validation and commissioning activities. Essential Duties and Responsibilities: Manage scheduling of all the facility and equipment calibration and preventative maintenance programs. The equipment includes but is not limited to AHUs, autoclave, RO/DI water system, CTUs, BSCs, scales and pumps, Etc. Perform routine facility inspection to ensure facility and equipment are in a state of control for cGMP activities. Oversee facility repair and upgrade, equipment upgrade shutdown planning. Maintain equipment history files, write and review PM and calibration documents, schedule outside service vendors and order some spare parts. Implement SOPs and documentation procedures for the facility and equipment scheduled and unscheduled maintenance. Education, Work Experience and/or Licensure Qualified person will have a HS/BS degree, preferably in an engineering discipline. Experience in the pharmaceutical industry in Facility Operations, Aseptic Manufacturing Operations, or contamination control-related department preferred. Experience in clean room facility is preferred. Good communication, interpersonal, organizational and customer services skills are essential. Proven troubleshooting skills, down to the component level and proficiency with all MS office products are necessary. Knowledge of HVAC and refrigeration system and GAMP 5 are preferred. Physical Demands
The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of his/her job. Under the ADA, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Ability to sit, stand, walk, travel up and down stairs, crouch, stoop and reach. Ability to lift up to 50 lbs.
