CTMC · 14 hours ago
Maintenance Engineer
Houston, TX
Full-time
Onsite
Senior Level
7+ years expCTMC is a pioneering biotech joint venture focused on accelerating cell therapies from bench to bedside. The Maintenance Engineer will provide technical oversight of Cell Therapy and Viral Vector equipment, ensuring compliance and operational efficiency throughout the equipment life cycle.
BiopharmaBiotechnologyTherapeutics
Hiring Manager
Jenifer Klemme
Responsibilities
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
Qualification
Required
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
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
Preferred
Previous experience with audits preferred
Company
CTMC
CTMC is a clinical cancer center to enable innovation from academia and biotech to accelerate cell therapy’s impact on cancer patients.
51-200 employees
H1B Sponsorship
CTMC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2022 (1)
Funding
Current Stage
Growth StageLeadership Team
Jason Bock
CEO
Houman Mesghali
Co-Founder and COO
Recent News
2025-05-17
Company data provided by crunchbase