Job Title: Maintenance Engineer

Work Location: Houston, Texas

Summary:

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.

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.
• Identify opportunities to optimize equipment performance, reduce costs, and enhance reliability through innovative solutions and best practices.
• Perform other duties as assigned.

Qualifications:

• Bachelor’s degree in Engineering.
• 7+ years relevant experience, preferably in the biotech industry or equivalent combination of education and experience.
• 4+ years 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.

Published Category: Manufacturing & Technical Operations