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The Cedars-Sinai Biomanufacturing Center (CBC) is a state-of-the art facility that comprises of a cGMP cell manufacturing facility housing multiple cleanroom cell production suites and process development rooms for producing the next generation of cell and gene therapies. With world class expertise in stem cell (iPSC) biology, bioprocessing, translational, regulatory and manufacturing, Cedars-Sinai is committed to pushing the frontiers of medicine and discovering new technologies and innovations that will impact how we diagnose and treat disease. To learn more about the CBC, please visit Home - CSBIO (csbiomfg.com).

We are seeking a Senior Maintenance Technician to be responsible for overseeing the routine and preventative maintenance for all cGMP and non-cGMP facility equipment along with cGMP compliance record keeping. As a Maintenance Tech III, work closely with vendors, associates, and management, utilizing effective communication to ensure that the facility and equipment is running to required compliance. This role will lead and administer training of new hires, assists with design, installation, and qualification of new equipment. Responds to validated Environmental Monitoring System alarms and assists in all general facility services as needed. Performs advanced tasks and completes the most-difficult assignments. Works under minimal supervision with considerable latitude for independent judgment. May mentor less-experienced peers and assist supervisors, but does not formally supervise others.

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Primary Duties and Responsibilities:

• Performs routine maintenance tasks including: maintenance of R&D labs and cGMP manufacturing equipment, plumbing repairs, office furniture installation, and general building repairs, and other as assigned.
• Troubleshoots, rebuild, overhaul, repair, maintain, modify and install various types of electrical and production equipment, tools and machinery as required.
• Performs root cause analysis of facility equipment, facility support utilities and manufacturing equipment failure.
• Responsible for facilities cGMP non-conformance and CAPA reports.
• Responsible for Bio-decontamination and appearance of all Manufacturing Production areas, Bulk Formulation, Aseptic filling.
• Requires understanding of building P&IDs, mechanical and electrical systems, as-builts, schematics and flow diagrams.
• Maintains a safe work environment; work in a safe manner following all safety SOP’s and wear Personal Protective Equipment as required.
• Maintains accurate record keeping of equipment and systems for cGMP compliance including calibration records.
• Works independently and make sound judgments regarding work methods and tools. Proactively support the Corporations, Companies, Departments and Personal goals and objectives.
• Coordinates and escort vendor services and monitor to ensure work is completed according to specifications.
• Ensures cGMP manufacturing, non-cGMP labs and lab personnel are supported to meet business needs, including: lab gasses, preventive maintenance, equipment service contracts and safety equipment.
• Assists in the design, installation, and qualification of new facility equipment and systems within scope of expertise.
• Monitors, maintains, and responds to Equipment Monitoring System Building Management Systems.
• Ensure clean rooms and general facility is maintained in optimum conditions and in compliance with GMP requirements.

Education:

• High School Diploma/GED, required. Bachelor's Degree in Engineering, Biotechnology, or related field, preferred.

Experience & Skills:

• Five (5)+ years of experience in GMP manufacturing or manufacturing, production facilities.
• Ability to apply knowledge of information software and/or hardware to provide solutions and/or support. Experienced with cGMP CFR Title 21 Part 11 code compliance for EMS and BAS.
• Ability to operate mechanical/medical devices and/or equipment, previous experience with VSD and HMI controls troubleshooting and programming.
• Ability to use software applications and operate technological devices, prior experience with MS Office BAS and cGMP EMS programs.
• Maintain up to date knowledge of applicable cGMP Code of Federal Regulations.
• Experience in communicating in an FDA regulated environment.
• Ability to provide and/or support a level of work excellence and accuracy; recognize and address flaws or errors that others may overlook.

Licenses and Certifications:

• Universal Refrigerant License, preferred.
• Project Management Professional (PMP), preferred.