Instrumentation & Equipment Specialist II

Responsibilities

• Perform preventative, routine, and corrective maintenance of CTUs, process utility systems, and manufacturing/laboratory instruments
• Calibrate, adjust, and maintain measuring and indicating instruments to conform to set standards
• Troubleshoot and repair PLC, HVAC, mechanical, and electrical systems
• Monitor, investigate, and respond to alarms from BMS/QEMS
• Support Metrology to investigate OOT events using root cause analysis
• Read and interpret engineering and architectural drawings, including P&IDs
• Write incident/deviation reports and perform root cause analyses
• Work with external vendors for equipment service and repair
• Provide on-call support as needed

Requirements

• Bachelor’s degree with 5 years of experience or Associates Degree with 10 years of experience
• 5-10 years of instrumentation and equipment experience in a GMP environment
• Experience with Blue Mountain CMMS
• Experience with Siemens Desigo or Insight BMS/EMS
• Ability to wear clean room attire and PPE, including half-face respirators
• Valid driver’s license
• Ability to lift up to 45 pounds and stand/walk for 90% of a 10-hour shift

Preferred Qualifications

• Prior experience in cell therapy manufacturing or BioPharma/Life Sciences
• Experience working under ISO/IEC 17025 and/or ANSI/NCSL Z540.3 management systems
• Familiarity with 21 CFR Part 11 and standard GxP best practices

About the Company

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells.