What are the responsibilities and job description for the Facilities Engineer position at TPP CDMO?
Company Description TPP CDMO is a global contract development and manufacturing organization focused on delivering high-quality pharmaceutical and biotech products. The company integrates advanced scientific development with centers of excellence in manufacturing and supply chain reliability to support its partners. With deep expertise in the U.S. pharma and biotech landscape, TPP CDMO emphasizes product quality, safety, and compliance.
Role Description This full-time, on-site Facilities Engineer role is based in San Diego, CA. The ideal candidate will possess strong expertise in sterile manufacturing equipment, cleanroom design, regulatory compliance, and process optimization and will possess bilingual (English and Mandarin Chinese) proficiency. The facilities engineer is responsible for supporting the troubleshooting, optimization, and ongoing maintenance of critical manufacturing systems used in aseptic fill-finish and lyophilization operations and provide technical support for facilities expansion initiatives.
Essential functions (other duties may be assigned)
- Provide technical support including troubleshooting of aseptic fill line and lyophilization systems
- Diagnose and resolve mechanical, operational, and process-related issues to minimize downtime and improve manufacturing reliability
- Use AutoCAD and or related engineering tools to design and revise manufacturing layouts, draft clean room and facility floor plans, document utility routing and equipment placement, maintain engineering drawing and change records
- Develop and optimize cleanroom layouts and manufacturing spaces to improve material flow, personnel flow, contamination control and operational efficiency
- Ensure facility and equipment compliance with cGMP requirements
- Support installation, commissioning, qualification, and startup of new manufacturing equipment and facility upgrades
- Ability to collaborate across engineering, facilities, validation, quality, and manufacturing teams
- Collaborate with vendors, contractors, and global engineering teams to support equipment selection, upgrades, maintenance, and technical investigations
- Ability to communicate technical issues effectively with English-speaking and Chinese-speaking teams, vendors, and stakeholders
- Oversees all compliance related issues including Corrective Action / Preventative Action Plans (CAPAs), Deviations, Periodic Reviews and Change Controls related to facilities and engineering projects.
- Lead and/or supervise the execution of engineering investigations into site modifications and expansions to meet business opportunities and regulatory requirements.