Maintenance Technician II

Description

•  Perform and prioritize PM activities for sanitary and non-sanitary utilities system (compressed air, WFI, RO/DI, chilled water, etc). Ensure timely completion of PM activity. 
• Help coordinate schedule for PM activities with stakeholders and other department functional heads. Communicate PM progress periodically to supervisor and stakeholders. 
• Ensure parts needed for PM are available. Create PM part kit as needed and monitor inventory of spare parts. 
• Document work order for completion in Blue Mountain RAM system. Ensure all supporting documentation are attached in the RAM system per work order. 
• Monitor BAS critical system/equipment alarm for any abnormal condition. Response and investigate alarm condition. Ability to react to emergency equipment / system issue.
• Ability to provide guidance, on-the-job training and sharing of expertise to other mechanics. 
• Operate and monitor boilers per CA Code of Regulation Title 8, Sec 781.
• Perform facilities, utilities system and equipment repair, modification and improvement. 
• Responsible for proper operation of major sanitary and non-sanitary utilities systems, HVAC and BAS system. 
• Interface and interacts with other functional department representative to troubleshoot and resolve complex facilities, utilities and equipment issues. 
• Assist senior technicians to execute small expense and capital projects. Assist and facilitate to carry out project tasks.
• Assist in deviation investigation and CAPA implementation. Assist with root cause investigation and product impact assessment as needed. 
• Supervise and coordinate with vendor and contractor for PM, repair and project execution. 
• Partner with EH&S representative to address safety and environmental issue. 
• Assist in revision of standard operating procedures as needed. 
• Create and execute Change Control or Critical Work Order to make changes to any GMP system or equipment. 
• Facilitate compliance with laws and regulations related to maintenance and operation activities (such as Boiler Permit, Pressure Vessel Permit)
• Ensure Eye Washes, Safety Showers and fire extinguishers are routinely inspected.
• Additional maintenance tasks as assigned 

Requirements

•  Minimum 5 years experience working in facilities and utilities maintenance.
• Minimum 3 years experience working in a biotech/pharmaceutical cGMP / cGLP environment.
• Trade school, training, certificate or equivalent work experience related to maintenance and facilities management is acceptable. 
• Technical knowledge and experience in sanitary and plant utilities system, such as WFI, plant steam, compressed air, chilled water, HVAC, and clean room.
• Competency in boiler operation and maintenance
• Ability to read and understand piping/instrumentation diagram, electrical diagram and construction drawing. 
• Experience in supervising vendors.
• Strong analytical and troubleshooting skills. Strong organizational skills.
• Good interpersonal skills, critical thinking, ability to multi-task effectively, make independent decisions, and resolve complex problems. Strong communication skills, both written and verbal, and active listening.
• Good computer skills, including the ability to use Microsoft Office.
• Working knowledge in change management and deviation processes preferred.
• Experience with GMP equipment qualification / validation preferred.