Joinn Biologics US Inc. is a Contract Development and Manufacturing Organization (CDMO) based in Richmond, CA, committed to the advancement of biopharmaceutics through premier services for biologics and advanced therapies. Joinn Biologics provides a range of services from early custom development to clinical manufacturing to clients on a global scale. We are well funded and backed by Joinn Laboratories, a publicly-listed company founded in 1995 as the first private preclinical CRO in China certified by US FDA. Joinn Biologics US Inc. is looking for a highly motivated and determined individual with expertise in Good Manufacturing Practice (GMP), biomanufacturing, facilities and laboratory support.

Essential Duties and Responsbilities:

• Responsible for the operation and maintenance of all development laboratory and GMP facilities and utilities.
• Manage the maintenance program for all process and laboratory equipment.
• Manage facilities systems and maintenance staff, including training, scheduling and review of activities.
• Manage facilities systems and maintenance staff, including training, scheduling and review of activities.
• Establish SOPs and performance metrics.
• Prepare, review and execute qualification and validation documents for facilities and clean utilities.
• Manage changes and deviations, as appropriate.
• Perform facility risk management and implement corrective plans.
• Ensure client confidentiality and data integrity.

Experience / Qualification:

• Minimum five (5) years management experience in GMP pharmaceuticalfacilities operation is required.
• Minimum of bachelor degree with major in mechanical, electrical or chemical engineering, or equivalent facilities experience is required.
• Experience in operation of GMP and non-GMP utilities and systems including HVAC, WFI, pure steam, clean dry air, process gasses, plant steam, chilled water, waste water, fire protection, electrical power, etc.
• Knowledgeable about cGMP compliance requirements for pharmaceutical manufacturing facilities.
• Excellent communication skills, leadership, and learning ability.
• Self-motivated and organized.

Work visa sponsorship not available; local candidates preferred.

Job Type: Full-time

Experience: Management: 5 years (Required)

Education: Bachelor's (Preferred)

Location: Richmond, CA 94806

Work authorization: United States (Required)