Senior Manager, Facilities Engineering

Overview

The Senior Manager, Facilities Engineering is responsible for managing the operation and optimization of the equipment, systems and utilities of a cGMP Cell Therapy Manufacturing Facility. Provide oversight and foster collaboration between the Maintenance and Metrology groups to develop programs for equipment maintenance and calibrations. Coordinate with the Facilities, Engineering, Operations, Supply Chain and Quality teams to ensure maximum uptime and efficiency of all systems and equipment.

Primary Responsibilities

• Support the installation, start-up, commissioning, and qualification of Facilities equipment, systems and utilities associated with cGMP Manufacturing, Laboratories and Warehouse.
• A strong understanding of HVAC, mechanical and electrical systems, and be able to troubleshoot as necessary is required.
• A strong understanding of building automation/control systems, plant engineering and operations is required.
• A strong understanding of metrology, calibrations and the use of a wide range of standards is required.
• Prior experience working with cell therapy processing and laboratory equipment is highly desirable, including; BSC’s, incubators, refrigerators, centrifuges, -80C freezers and LN2 freezers.
• Develops and collaborates on reliability and predictive maintenance programs and solutions for increasing uptime and for equipment problems that affect the manufacturing process.
• Provide technical and engineering expertise and support to all departments as needed.
• Monitor and respond to alarms generated from the BMS/QEMS, including off-hours and weekends.
• Lead critical level investigations as related to facilities alarms and deviations. Approve deviations, non-conformances, and CAPAs as required. Partner with Quality to address these issues effectively and compliantly.
• Develop and continuously improve departmental standard operating procedures.
• Maintains records on equipment manufacturers’ technical notices, upgrades and safety issues.
• Calculate and organize data for process flow sheets including instrumentation and control considerations.
• Participate in the planning, design, budgeting, scheduling and execution of assigned projects.
• Independently applies advanced engineering techniques and analysis and provide technical guidance to less experienced design and engineering personnel.
• Training Maintenance, Metrology and Engineering staff, where appropriate.
• Conduct routine inspections of premises and equipment.
• Investigating problems and diagnosing and repairing faults.
• Oversee work performed by maintenance and/or external contractors to ensure conformance to design and industry standards.
• Ensure safe working conditions.
• Other duties as required.

Position Requirements

• BS or MS in Engineering field is required, or equivalent experience.
• 10 to 15 years of related BioPharma/Life Sciences experience required. Prior experience in cell therapy manufacturing is highly desirable.
• Has comprehensive understanding of principles, theories, concepts, and industry practices and standards and their application.
• Extensive knowledge of small-scale cell culture processes and techniques is preferred.
• Experience interfacing with other design disciplines including automation, facility design and mechanical design groups is required.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations is required.
• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
• Experience interfacing with CQV and operations teams is required.
• Experience in scheduling and budgeting Facilities & Process Engineering efforts is highly desirable.
• Experience using Computerized Maintenance Management Software (Blue Mountain) is preferred.
• Experience using Building Management Systems (Siemens - Apogee/Desigo) and Environmental Monitoring Systems is required.
• Demonstrable experience on cGMP capital, maintenance and operating projects.
• Excellent oral and written communication skills required.

Physical Requirements

Ability to lift 20lbs

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