Facilities Engineer

Iovance Biotherapeutics•Philadelphia, PA

14d•Onsite

About The Position

The Facilities Engineer is responsible for the operation and optimization of the equipment, systems, and utilities of a GMP Manufacturing Facility. This role dedicates approximately 50% of it’s time supporting the Cell Therapy Center manufacturing facility located at 300 Rouse Blvd, Philadelphia, PA as well as a satellite GMP manufacturing facility located at 700 Spring Garden St, Philadelphia, PA.

Requirements

BS or MS in Engineering or Technical field is required, or equivalent experience.
3+ years of related BioPharma/Life Sciences experience required.
Has comprehensive understanding of principles, theories, concepts, and industry practices and standards and their application.
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 other design disciplines including automation, facility design and mechanical design groups is required.
Experience interfacing with CQV and operations teams is required.
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.

Nice To Haves

Prior experience in cell therapy manufacturing is highly desirable.
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 preferred.
Experience using Computerized Maintenance Management Software (Blue Mountain) is preferred.

Responsibilities

Demonstrate a strong understanding of HVAC, mechanical and electrical 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, -80C freezers and LN2 freezers.
Monitor the utilities (CO2 and LN2) at the Spring Garden location daily, reorder and replace equipment to ensure reliable and uninterrupted supply.
Provide engineering and/or technical expertise and support to all departments as needed.
Provide engineering and/or project management support for all Facilities projects.
Monitor and respond to alarms generated from the BMS/QEMS, including off-hours and weekends.
Schedule, coordinate and escort external vendors for maintenance and calibration activities
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.
Conduct routine inspections of premises and equipment.
Investigating problems and diagnosing and repairing faults.
Ensure safe working conditions.
Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
Perform miscellaneous duties as assigned.