Description

JOINN Biologics (JOINN Bio) is a Bay Area, California-based company that is committed to the advancement of biopharmaceutics through its premier contract development and manufacturing services for biologics and advanced therapies. JOINN Biologics aims to provide a complete range of services from early custom development to clinical manufacturing to our global clients. We work closely with our partners and clients to further accelerate the development of high-quality biologics and deliver long-lasting value to the biopharmaceutical industry. 

Joinn Biologics US Inc. is looking for a highly motivated and determined individual with expertise in Facilities Engineering, Maintenance, and Calibration of GMP biomanufacturing facilities and equipment.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

· Responsible for the operation and maintenance of Joinn facilities and utilities.

· Responsible for facility engineering and design evaluation and upgrades. 

· Manage the maintenance program for all utilities, process and laboratory equipment.

· Manage the calibration program for all utilities, process and laboratory equipment.

· Manage the Environmental Health and Safety (EHS) program.

· Manage building monitoring systems, including alarm monitoring and remediation.

· Manage facilities maintenance and calibration staff, including training and performance evaluations.

· Responsible for all facility and utility documentation, including drawings, SOPs, validation documents, etc.

· Responsible for cGMP compliance of all facility systems.

· Perform facility risk management and implement corrective plans.

· Ensure client confidentiality and data integrity.

Requirements

EXPERIENCE / QUALIFICATION:

• Minimum five (5) years facility management experience in GMP pharmaceutical facilities 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.

Local candidates preferred