Facilities Manager

About Us :

Cue Health (Nasdaq: HLTH) is a mission-driven healthcare technology company that puts consumers in control of their health information and places diagnostic information at the center of care. Cue Health enables people to manage their health through real-time, actionable, and connected health information, offering individuals and their healthcare providers easy access to lab-quality diagnostics anywhere, anytime, in a device that fits in the palm of the hand. Cue Health’s first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without physician supervision. Outside the United States, Cue Health has received the CE mark in the European Union, Interim Order authorization from Health Canada, and regulatory approval from India’s Central Drugs Standard Control Organisation. Cue Health was founded in 2010 and is headquartered in San Diego. For more information, please visit www.cuehealth.com .

Cue Health Inc. is seeking to hire a full-time Facilities Manager. The Facilities Manager will partner and work on Facilities Maintenance functions to assure reliable, cost effective manufacturing process and packaging operations in compliance with FDA guidelines and current Good Manufacturing Practices (GMP) to ensure reliable, cost effective manufacturing process and packaging manufacturing operations. Responsibility includes the execution of Preventive Maintenance, Corrective Maintenance and Emergency work, as needed.

Responsibilities:

• Assists the Facilities Maintenance functions to assure reliable, cost effective manufacturing process and packaging operations in compliance with FDA guidelines and current Good Manufacturing Practices (GMP) to ensure reliable, cost effective manufacturing process and packaging manufacturing operations

• Ensure that building infrastructure of the GMP areas are maintained and in compliance

• Ensure all utilities are operational and properly maintained

• P erforms mechanical, electrical and automatic controls maintenance activities in a GMP manufacturing operation

• Manage JMG Security Badge and alarm codes for employees

• Identifies/addresses equipment/system opportunities for improvement and provides engineering and technical expertise in the execution of equipment/system maintenance

• Maintain all mechanical and electrical maintenance activities related to manufacturing process equipment; maximizing technician’s /mechanic’s utilization

• Responsible to provide technical support as needed. Support of validation/qualification protocols (IQ/OQ/PQ) with task related to equipment maintenance to execute in a timely manner

• Promote safety and participate in safety activities

• Manage pest control, janitorial, security and other facility service contracts

• Support or coordinate space planning activities

• Ensure compliance with change control procedures. Ensure the manufacturing PLC/PC systems programs are well documented and archived, and all changes are made following change control process and applicable procedures. Support continuous improvement in equipment uptime and reliability metrics to achieve manufacturing schedule and OGSM objectives

• Performs reviews of Maintenance documentation to ensure documentation and performance is compliant with Cue’s policies, procedures, quality standards and current Good Manufacturing Practices (cGMP), as well as safety and environmental regulations, as needed

• Approve maintenance work orders related to work performed by maintenance personnel and contractors

• Must be able to respond during off hours to cover/address emergency situations

• Orders parts or spares for production equipment and perform appropriate follow-up to assure timely delivery

• Negotiates and maintains contracts with third party vendors

• Other duties as defined

Requirements:

• A minimum of (4) years of experience in the Maintenance/Engineering field in a Pharmaceutical or Chemical Process industry is desired

• A bachelor’s degree in science of Mechanical or Electrical/Electronic Engineering required

• Familiar with World Class maintenance concepts such a Reliability Center Maintenance, Total Productive Maintenance, FMEA, FMECA, Maintenance Planning & Scheduling, and Predictive Maintenance among others

• Familiar with Lean Manufacturing and Six Sigma concepts

• Experience maintaining equipment in Compounding and Fill & Pack manufacturing environment is desired

• Experience leading projects and initiatives related to Safety, GMP Compliance and Cost Improvement is desired

• Demonstrated leadership and team-oriented skills

• Ability to communicate effectively with customers regarding needs and meeting expectations

• Ability to apply negotiation skills in dealing with customers, vendors, governmental agencies, and others

• Advanced Computer skills (Excel, Word, etc.)

• Hands on experience installing, maintaining and troubleshooting PLCs, Automatic Process Controls and Computer Supervisory controls are highly desired

• Knowledge of FDA, cGMP’s regulations, OSHA and other governmental regulations

• Ability to adapt and promote new technologies and processes in a changing maintenance and operational culture. Innovative thinking. Ability to work in a team environment

Environment and Physical Activities/Requirements:

• You will work in an indoor manufacturing environment, which may occasionally be noisy, subject to climate and humidity requirements, and hazardous substances. This position requires the following physical activities and/or requirements:

  • Remaining in a stationary or sedentary position, often standing and/or sitting for prolonged periods of time

  • Moving about to accomplish tasks or moving from one worksite to another, including possibly tight or confined spaces

  • Reaching, crouching, or stooping

  • Repeating motions that may include the wrists, hands, and/or fingers

  • Adjusting, moving, carrying, lifting, pushing or pulling objects up to 50 pounds

  • Operating machinery, power tools, motor vehicles, and/or heavy equipment

  • Ascending or descending ramps, ladders and/or stairs

  • Communicating with others to exchange information

  • Visual acuity, including peripheral vision

Your contribution will set the pace and have an impact in the technology, health, and diagnostic industry. Your work and ideas will be valued and respected, and we hope you will find enjoyment working with a collaborative team on an innovative device. We offer upgraded computer equipment, unlimited snacks, and a competitive salary.

Cue Health Inc. is an equal opportunity employer, consistent with applicable laws. Individuals seeking employment are considered without regards to race, color, religion (including religious accommodations), creed, sex (including pregnancy, childbirth and related medical conditions), gender (including gender identity and expression), sexual orientation, marital status, national origin (including language use restrictions), ancestry, mental and/or physical disability, medical condition (cancer, genetic information and characteristics, requests for medical and family care leave), age, military or veteran status, and any other classification protected by applicable federal, state, and local laws.