Maintenance Engineer - Houston - Resilience Texas LLC

    Resilience Texas LLC
    Resilience Texas LLC Houston

    1 week ago

    Description
    Location: Houston, TX (Onsite)
    Department: Equipment
    Reports to: Manager, Equipment
    About CTMC
    CTMC is a pioneering biotech joint venture, formed by National Resilience and MD Anderson Cancer Center, located in the heart of the Texas Medical Center. Our mission is to accelerate cell therapies from bench to bedside. We offer a wide range of cell therapy modalities, including CAR-T, TIL, and TCR-T. Our expert team collaborates closely with MD Anderson's research and clinical faculty, bringing impactful cell therapies to cancer patients.
    Since inception in May 2022, our team has filed eight INDs and have received approval, without delay, demonstrating our commitment to delivering innovative treatments to patients with speed and precision. Our alliance with National Resilience enables us to remain at the forefront of biomanufacturing practices, leveraging advanced technology and processes to deliver exceptional results.
    Our growing, state-of-the-art, 60,000 sq. ft. industrial facility in the Texas Medical Center is staffed by an integrated team of industry veterans and academic scientists who are passionate about bringing life-saving cures to patients. Our unique joint venture structure, with two highly established partners, provides us with the financial stability and long-term horizon to achieve our organizational goals.
    At CTMC, we value our employees and offer a variety of development opportunities within our novel corporate structure to inspire professional growth and satisfaction. We foster a team-first culture and a balanced work-life environment to ensure our staff is energized and engaged in our mission to accelerate cell therapies from bench to bedside for patients who need them. If you share our passion for advancing the frontiers of medical science with innovative therapeutics and want to join a highly dedicated team committed to delivering novel cures to patients, we invite you to submit your application. We look forward to hearing from you and exploring how your skills and expertise can help us achieve our mission.
    Responsibilities
    As an Equipment Engineer, you will provide technical oversight of all Cell Therapy and Viral Vector equipment and will work with the Manufacturing and Quality Control departments during the full equipment life cycle. This role supports day-to-day operations, equipment qualification, preventive maintenance, and troubleshooting across all critical GMP departments, including such equipment as incubators, Biological Safety Cabinets, Lovos, Prodigies, and any new Cell Therapy equipment.
    • Establish and maintain preventive and predictive maintenance programs to maximize equipment uptime.
    • Troubleshoot equipment issues, perform root-cause analyses, and drive corrective actions.
    • Collaborate with external service providers to ensure timely, compliant service activities.
    • Update Maximo CMMS promptly upon completion of maintenance tasks.
    • Author and execute IQ/OQ/PQ protocols in compliance with GMP and regulatory guidelines (FDA, ICH).
    • Partner with Quality, Validation, and Manufacturing teams to ensure equipment qualification documentation is accurate and audit ready.
    • Manage equipment change controls and support technical assessments for deviations and CAPAs, ensuring adherence to timelines.
    • Train manufacturing and laboratory staff on proper equipment operation procedures, when required.
    • Ensure that changes, maintenance and other interventions do not adversely impact the qualification state of the equipment.
    • Lead/support the tech transfer of new equipment and unit operations across Equipment development and manufacturing
    • Provide technical oversight during development of equipment and Equipment system User Requirements and related Design Review/Qualification documentation to ensure equipment and systems are appropriate for intended purpose.
    • Provide guidance in development of test plans for Verification packages and associated critical components.
    • Provide guidance on key elements of return to service requirements for equipment after interventions such as maintenance.
    • Assist during internal and external audits, providing technical expertise and documentation as required.
    • Assist and support routine maintenance activities, if required.
    • Work cross functionally among Equipment Development, Manufacturing, Quality Control, Quality Assurance, IT and other departments as assigned.
    • Meet and report key performance indicators in alignment with Cell Therapy Manufacturing and CTMC goals.
    • Identify opportunities to optimize equipment performance, reduce costs, and enhance reliability through innovative solutions and best practices.
    • Perform other duties as assigned.
    Qualifications/Skills
    • Bachelor's degree in Engineering.
    • 7+ yr's. relevant experience, preferably in the biotech industry or equivalent combination of education and experience.
    • 4+ yr's. experience in a regulated manufacturing environment.
    • Proficient with Microsoft Office: Word, Excel, Outlook and Teams.
    • Experience in Equipment Development laboratory operations with various cell manufacturing platforms including closed systems for the development of T-cell therapy products.
    • Demonstrated ability to collaborate effectively in a multi-disciplinary team.
    • Demonstrated strong communication skills, interpersonal skills and a superior drive for results.
    • Excellent written, oral, interpersonal and presentation skills and the ability to effectively interface with senior management and staff.
    • Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills.
    • Previous experience with audits preferred.
    • Meticulous attention to detail in terms of documentation and following SOPs.
    • Able to work a flexible schedule including nights, weekends, and holidays with short advance notice.
    Working Conditions, Equipment, Physical Demands
    The incumbent in this position works in an office, labs, and clean room environments. The incumbent in this position will use the following equipment and shall have the following physical demands:
    Equipment-
    • Computer
    • Printer
    • Facsimile
    • Telephone
    • Manufacturing equipment
    Physical Demands-
    • Frequent standing, walking, sitting, and reaching required.
    • Frequent lifting up to 10 lbs. required.
    • Occasional lifting, pushing, and pulling up to 50 lbs. required.
    • Frequent use of computer/keyboard required.
    The physical demands and work environment that have been described are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with the Americans with Disabilities Act.
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