Sr Principal Plant_Facilities Engineer

Senior Facilities Engineer

South San Francisco, CA

Position Summary:

This role will be key in providing support to the engineering activities related to plant facilities and equipment of a new clinical GMP manufacturing for a leading cell therapy company. An opportunity to build a manufacturing facility ground up for our pivotal/commercial facility.

Key Responsibilities:

• Assist with the coordination and execution of activities concerned with the design, modification, and maintenance of equipment and facility.
• Work with Validation, quality, and manufacturing to review and approve URS, System Impact Assessment, C&Q reports, and protocols. Generate/Create Asset Enrollments, and sops for Facilities and Utility systems.
• Establish Service contracts for Facilities and Utility Systems.
• Investigate and troubleshoot issues during routine operations tied to the facility and manufacturing equipment.
• Understand the functioning of different facility/ engineering equipment to setup maintenance and calibration activities.

Position Requirements and

Education:

• Bachelor’s degree preferably in Life Sciences or Engineering related field with 5 years or more of experience in biologics, pharmaceuticals or cell therapy preferred.
• Experience in at least 2 of the areas required:
  System start-up, HVAC, Isolator and Filler System, Process Gas systems (CDA, CO2, O2, N2), Vacuum System, Environmental Monitoring System (Vaisala), Building Management System (BMS), Chiller & Condenser system.
• Has deep knowledge of pharmaceuticals and biotech production processes and industry.
• Strong aptitude to ward problem-solving and troubleshooting.
• Proactive person who is a self-starter and looks at identifying problem statements and comes up with innovative and effective solutions.
• Have some direct/indirect experience guiding and managing young engineers.
• Applied knowledge of cGMP guidelines and quality required.