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Facility Maintenance Leader
RadioMedix, Inc.United Statesfull_timeVerifiedPosted 16 Sept 2025
About the role
RadioMedix Inc., a Biotechnology Company located in Humble, Texas, is seeking a Facility Maintenance Leader to work in its newly constructed GMP radiopharmaceutical manufacturing facility.
Job Description:
Our mission is to ensure a safe, compliant, and efficient facility environment that enables the highest standards of GMP manufacturing and laboratory operations. We are dedicated to maintaining 100% operational readiness of all utilities, systems, and equipment through proactive maintenance, continuous improvement, and regulatory excellence. By fostering a culture of safety, accountability, and teamwork, we support innovation, protect product integrity, and contribute to the success of our organization and the patients we ultimately serve.
Responsibilities
Residency Requirement:
Work Environment:
Location: RadioMedix Spica Center, 19705 Aldine Westfield Rd, Humble, TX
Work Conditions:
The work period is typically an 8-hour shift between 8:30 A
Job Description:
Our mission is to ensure a safe, compliant, and efficient facility environment that enables the highest standards of GMP manufacturing and laboratory operations. We are dedicated to maintaining 100% operational readiness of all utilities, systems, and equipment through proactive maintenance, continuous improvement, and regulatory excellence. By fostering a culture of safety, accountability, and teamwork, we support innovation, protect product integrity, and contribute to the success of our organization and the patients we ultimately serve.
Responsibilities
- Serve as the primary on-call contact for after-hours alerts from controlled/monitored regulated spaces.
- Draft, review, execute, and maintain technical documentation (e.g., SOPs, protocols, reports, and development records).
- Schedule and oversee all environmental quality activities across manufacturing and QC laboratories, including cleaning and maintenance of GMP spaces.
- Support implementation of new equipment technologies (e.g., hot cells, QC analytical instruments, refrigerators, freezers, incubators).
- Manage operational performance and qualification of equipment, including preventive maintenance, calibration, repairs, installation, and utility systems (HVAC, water, steam, control systems) within GMP compliance.
- Coordinate with facility engineers on repairs of specialized equipment (e.g., hot cells, manipulators, mechanical systems).
- Contribute to facility expansion projects, system upgrades, and quality control improvements.
- Evaluate and optimize operational systems and facility infrastructure to improve efficiency and resource utilization.
- Plan and manage maintenance schedules, contractor activities, and infrastructure projects.
- Oversee and ensure compliance of external contractors (security, pest control, waste management, fire systems, landscaping).
- Ensure adherence to regulatory standards, building codes, and health & safety requirements.
- Prepare reports, audit responses, and compliance documentation.
- Perform environmental monitoring per USP <116>, cGMP, and ISO 14644-1 standards (including sampling of ISO 5, ISO 7, and ISO 8 areas).
- Support radiation safety surveys, waste management, and GMP documentation.
- Perform assigned preventive cleaning, maintenance, and work orders on time, ensuring proper recordkeeping.
- Maintain proper housekeeping and facility readiness at all times.
- Assist in building maintenance and other duties as assigned.
- Bachelor’s degree required; technical or engineering discipline preferred.
- Strong verbal and written communication skills.
- Demonstrated troubleshooting and problem-solving ability.
- Proven project management skills in regulated or GMP environments.
- Experience with ISO-rated cleanrooms, GMP manufacturing, and laboratory support.
- Knowledge of facility utilities (HVAC, water/steam systems, building control systems) and GMP requirements.
- Ability to lead, coach, and mentor maintenance personnel.
- Experience managing facility support contractors.
- Participation in client and regulatory audits with proven ability to respond and implement corrective actions.
- Commitment to maintaining 100% operational readiness of facility utilities and equipment in compliance with cGMP SOPs.
Residency Requirement:
- Employees must permanently reside and work in the State of Texas.
Work Environment:
Location: RadioMedix Spica Center, 19705 Aldine Westfield Rd, Humble, TX
Work Conditions:
The work period is typically an 8-hour shift between 8:30 A
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