Manager, Facilities Engineer - R&D Partners

Overview

The Manager, Facilities Engineering is responsible for oversight of the technical Facilities and Plant Engineering teams responsible for supporting the Maintenance and Metrology functions at multiple GMP Facilities. Provide project engineering and project management support for mid-large CapEx construction/fit-out projects. Coordinate with the Maintenance, Metrology, Process Engineering, Operations, Supply Chain and Quality teams to ensure maximum uptime and efficiency of all systems and equipment.

Essential Functions and 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.
• Initiates various personnel actions to include recruiting, onboarding, performance management, training, promotions, and transfers to build a technical support team capable of supporting cGMP Facilities.
• Prior experience working with cell therapy process, analytical and laboratory equipment is required.
• 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.
• 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.
• Other duties as required.

Required Education, Skills, and Knowledge

• BS or MS in Engineering field is required, or equivalent experience.
• 10 to 15 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.
• 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.

Preferred Education, Skills, and Knowledge

• Prior experience in cell therapy manufacturing is highly desirable.

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.
• Able to stand and/or walk 90% (and sit 10%) for the full day which may include climbing ladders or steps.
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing 45 pounds.