Job Description

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

The Supervisor, Engineering & Maintenance is responsible for oversight of engineering, maintenance and calibration activities during second shift at Iovance iCTC. This position will be responsible for resolving escalations, technical issues and making sound critical decisions. Typical day to day activities include supporting the repair and maintenance of equipment, utilities and systems serving cGMP Manufacturing, Laboratories and Warehouse facilities. Ensure planned and corrective maintenance is performed according to written instructions, diagnose issues in the field in real-time, propose corrective solutions, solve issues as they arise and complete and review related Facilities Engineering GMP documents.

Essential Functions and Responsibilities

• Provide direction, coordination and support to maintenance and calibration functions.
• Demonstrate a strong understanding of HVAC, mechanical, electrical and process utilities systems, and be able to troubleshoot and repair.
• Demonstrate a strong understanding of cell therapy processing and analytical equipment and be able to troubleshoot and repair.
• Ability to read and interpret engineering and architectural drawings, including floor plans, reflected ceiling plans, power plans, panel schedules, mechanical/plumbing piping diagrams, Piping & Instrumentation Diagrams (P&IDs)
• Accountable for the safety of all personnel and equipment within the facility.
• Monitor and respond to alarms generated by the Building Management System and environmental monitoring system, including off-hours and weekends.
• Receive, filter and assign work order requests as necessary.
• Establishes/improves programs and solutions for increasing up-time and for equipment problems that affect the manufacturing process.
• Work with external vendors for the service and/or repair of equipment.
• Conduct routine inspections of premises and equipment.
• Investigating problems, diagnosing and repairing faults or issues.
• Maintains team capability and readiness via training, performance reviews, and hiring new Maintenance Calibration Technicians when necessary.
• Other duties as required.

Education and Qualifications

• BS or MS in Engineering field is required, or equivalent experience.
• 5 to 10 years of related BioPharma/Life Sciences experience required. Prior experience in cell therapy manufacturing is highly desirable.
• 3-4 years’ experience managing maintenance and calibration functions and personnel.
• A strong background in operations and maintenance of chiller plants, boiler plants, pumps and HVAC equipment is required.
• A strong background in operations and maintenance of electrical systems, including Emergency Generators, ATS’s and Switchgear is required.
• Experience using Computerized Maintenance Management Software (Blue Mountain RAM) is required.
• Experience using Building Management Systems and Environmental Monitoring Systems (Siemens Desigo or Insight) is required.
• Excellent oral and written communication skills required.
• Must have a valid driver’s license.
• Ability to respond to critical facility alarms/alerts including on-call and off hours.

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 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%) 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 50 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 deadlines.

Work Environment

• This position will work in both an office, manufacturing cleanrooms and lab setting.
• When in the lab, must be able to work in a lab with possible 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.
• Fast paced continuous biotech manufacturing environment with sometimes stressful conditions and situations.

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