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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.
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