Job Abstract

Overview

The Facilities Engineer is responsible for the operation and optimization of the equipment, systems and utilities of a cGMP Cell Therapy Manufacturing Facility. Collaborate with Maintenance and Metrology groups to develop programs for equipment maintenance and calibrations. Provide engineering and project management support for Facilities projects. Coordinate with the Facilities, Engineering, Operations and Quality teams to ensure maximum uptime and efficiency of all systems and equipment.

Essential Functions and Responsibilities

• Support the installation, start-up, commissioning, qualification and maintenance of Facilities equipment, systems and utilities associated with cGMP Manufacturing, Laboratories and Warehouse.
• Demonstrate a strong understanding of HVAC, mechanical, electrical and control systems, and be able to troubleshoot as necessary.
• Prior experience working with cell therapy processing and laboratory equipment is highly desirable, including; BSC s, incubators, refrigerators, centrifuges, Flow Cytometers, BacT, LOVO, NC-200, -80C freezers and LN2 freezers.
• Support the maintenance and metrology functions by scheduling/escorting vendors, performing technical reviews, ordering/maintaining spare parts.
• 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 building automation and environmental monitoring systems, including off-hours and weekends.
• Responsible for launching investigations, deviations, CAPAs, etc. related to GMP facilities, utilities, and equipment.
• Develop and enhance departmental standard operating procedures.
• 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.
• Conduct routine inspections of premises and equipment.
• Investigating problems and diagnosing and repairing faults.
• Making improvements to and offering advice about operational procedures.
• 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.

Required Education, Skills, and Knowledge

• BS or MS in Engineering field is required, or equivalent experience.
• 5 years of related BioPharma/Life Sciences experience required.
• 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.
• 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 using Computerized Maintenance Management Software (Blue Mountain) is preferred.
• Experience using Building Management Systems (Siemens - Apogee/Desigo) and Environmental Monitoring Systems is preferred.
• Demonstrable experience on cGMP capital, maintenance and operating projects.
• Excellent oral and written communication skills required.

Preferred Education, Skills, and Knowledge

• Prior experience in cell therapy manufacturing.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required:

• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
• Must meet requirements for and be able to wear a half-face respirator.
• Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps.
• Must be able to use near vision to view samples at close range
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing 20 pounds.