Instrumentation & Equipment Specialist II (3rd Shift Sunday - Wednesday, 10:00pm - 8:30am)

The role

The Instrumentation and Equipment Specialist II performs maintenance, calibration, and repair of equipment, utilities, and systems. This work supports cGMP Manufacturing, Laboratories, and Warehouse.

What you will do

• Perform preventative, routine and corrective maintenance of CTU's, process utility systems, and manufacturing/laboratory instruments.
• Perform routine inspections of the facility, equipment and systems.
• Monitor, investigate and respond to alarms generated from the BMS/QEMS.
• Support Metrology to investigate OOT events using root cause analysis.
• Read and interpret engineering and architectural drawings.
• Write incident/deviation reports and perform root cause analyses.
• Receive, filter and execute work order requests.
• Ensure equipment repairs or maintenance activities are compliant with building codes.
• Work with external vendors for the service and/or repair of equipment.
• Provide On-Call support as needed.

Required qualifications

• Bachelor’s degree with 5 years of experience or Associates Degree with 10 years of experience
• 5-10 years of related instrumentation and equipment experience in a GMP environment
• Experience using Computerized Maintenance Management Software (Blue Mountain)
• Experience using Building Management Systems and Environmental Monitoring Systems (Siemens Desigo or Insight)
• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE)
• Excellent oral and written communication skills
• Must have valid driver’s license
• Must be able to wear a half-face respirator
• Able to stand and/or walk 90% of a 10-hr day
• Able to climb ladders or steps
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions
• Able to lift and carry objects weighing 45 pounds

Nice to have

• Prior experience in cell therapy manufacturing or BioPharma/Life Sciences
• Experience working under ISO/IEC 17025 and/or ANSI/NCSL Z540.3 management systems
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations
• Understanding of calibration / metrology
• Understanding of PLC’s, HVAC, mechanical and electrical systems
• Knowledge in the use of a wide range of standards, including temperature, relative humidity, differential pressure, CO2, flow, conductivity, resistivity, speed, time, pressure, and weight

About the company

Iovance Biotherapeutics, Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. The company operates as an end-to-end cell therapy company with centralized U.S.-based manufacturing.