Facility Tech at Cellular Biomedicine Group Inc – Rockville, Maryland

Job Summary:

AbelZeta is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products. AbelZeta operates a state-of-the-art facility in Rockville, Maryland with five GMP rooms to augment its global research and development capabilities and support clinical development of multiple cell therapy platform technologies in the United States. We are on a rapid growth trajectory and have a highly energized and accomplished team driving new frontiers of care for cancer patients.

We are seeking a Facilities Technician to join our team. The Facilities Technician is responsible for ensuring the effective and efficient operation of the facilities and critical utilities and for the complex-level repairs, troubleshooting, and preventative maintenance of equipment and systems in compliance with cGMP requirements. The technician must be able to work both independently and as a team member and must possess considerable independent judgment and innovation to solve challenging and complex issues. The Facilities Technician will lead efforts supported by Facility Manager and other technical staff.

Responsibilities and Duties:

Support general facilities systems, HVAC, Compressed Air, Vacuum and Laboratory Gas Systems, Electrical, Minor Plumbing, all controlled temperature boxes, and house air conditioning units by performing maintenance, basic repairs and troubleshooting in compliance with all quality and safety standards.

• Ensure work is appropriately communicated to system operators and key stakeholders, including timelines and any issues that impact the work area, to avoid disruptions.
• Perform Preventative Maintenance procedures and troubleshooting for GMP manufacturing and QC equipment as defined by specific equipment protocols. Assist in troubleshooting mechanical and automated equipment issues to ensure optimal functionality while adhering to cGMPs and in the execution of ongoing validation efforts.
• Prepare maintenance, quality, and other documents/reports following good documentation practices, including deviations, corrective actions preventative actions (CAPA), change controls, and SOP revisions. Maintain equipment records including new equipment forms and system life cycle documentation.
• Troubleshoot plant operational, mechanical, and electrical problems and provide corrective action.
• Follow and promote on-the-job safety expectations, including wearing proper Personal Protective Equipment (PPE) and following cGMP rules and guidelines in all designated areas.
• Perform “On-Call” emergency duties requiring a 1-hour response time to the facility.
• Monitor and adjust building systems as needed and respond to after-hour notifications from BMS and/or employees.
• Must have reliable transportation.
• Perform other duties and essential tasks assigned.

Qualifications and Requirements:

Preferred Qualifications:

• Maintenance experience in a biotech or pharmaceutical company with direct experience with GMP facility operation
• Building or Hospital Management Systems, HVAC automation controls, energy management systems, or other related experience

Demonstrated understanding of systems needed to run a GMP facility such as: HVAC, electrical, process systems, plumbing/piping, general maintenance, pest management, both interior and GMP facility operation