Biotech GMP Facilities Technician II

ZylidacBio; Emeryville (CA); Hybride; USD 110 000 - 130 000; Plein temps

Résumé du poste

ZylidacBio is seeking a skilled Facilities Technician to perform and prioritize preventive maintenance on sanitary and non-sanitary utilities, including WFI, compressed air, RO/DI, and HVAC systems. The role requires coordinating PM schedules, managing parts inventories, and documenting work orders in the RAM system while responding to BAS alarms and emergencies.

You will train other mechanics, supervise vendors, and collaborate with EH&S to address safety issues, ensuring compliant operation of

Qualifications

• Minimum 5 years experience in facilities and utilities maintenance.
• Minimum 3 years experience in biotech/cGMP / cGLP environment.

Responsabilités

• Perform and prioritize PM activities for sanitary and non-sanitary utilities systems; ensure timely completion.
• Coordinate PM activity schedules with stakeholders and report progress to supervisor.
• Ensure parts for PM are available; create PM part kits and monitor spare parts inventory.
• Document work orders in Blue Mountain RAM; attach supporting documentation per work order.
• Monitor BAS system alarms; respond to abnormal conditions and emergencies.
• Provide on-the-job training and share expertise with other mechanics.

Connaissances

Facilities maintenance

Troubleshooting

Analytical skills

Organizational skills

Interpersonal communication

Reading diagrams

Vendor supervision

Microsoft Office

Change management

Formation

Trade school or equivalent

Outils

Blue Mountain RAM system

Description du poste

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.