Description

As a Sr. Principal Plant/Facilities Engineer you will: Job Description 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, SOP’s 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 toward 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. • Detail oriented with great communication skills both oral and written.

Key Skills
Education

ANY GRADUATE