Facilities Engineer

Overview

The Facilities Engineer is a part of the Technical Services team. This individual is an autologous ready-to-infuse cell therapy that has demonstrated distinctive efficacy in the treatment of metastatic melanoma. The company has Phase 2 clinical trials in progress for squamous cell carcinoma of the head and neck cervical carcinoma non-small cell lung cancer and immunotherapy for solid tumors. The company currently is developing its commercial manufacturing capacity to support development and launch of these assets.

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 its 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 -located at the American Red Cross Penn/Jersey Region this Iovance facility produces a critical raw material used in the companys TIL process.

This individual is directly responsible for coordinating all Facilities Engineering activities at the Spring Garden location and will interface with MS&T as well as the property owner for all Facilities and Maintenance related activities.

Essential Functions and 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; BSCs 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.

Required Education Skills and Knowledge

• 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.

Preferred Education Skills and Knowledge

• 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.

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.
• Able to crouch bend twist reach and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing 45 pounds.

Mental:

• Clear and conceptual thinking ability; excellent judgment troubleshooting problem-solving analysis and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline

Work Environment:

• This position will work in both an office and a manufacturing lab setting.
• When in the lab must be able to work in Lab setting with various chemical/biochemical exposures including latex and bleach.
• Able to work in cleanroom with biohazards human blood components and chemicals.
• Potential exposure to noise and equipment hazards and strong odors.

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The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions duties or local variances. Management retains the discretion to add or to change the duties of the position at any time.

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