Instrumentation & Equipment Specialist II

Instrumentation & Equipment Specialist II

Philadelphia

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 Instrumentation and Equipment Specialist II is responsible for the maintenance, calibration and repair of equipment, utilities and systems supporting cGMP Manufacturing, Laboratories and Warehouse. Perform planned and corrective maintenance and calibration according to written instructions, diagnose issues in the field in real‑time, propose corrective solutions, and complete and review related Facilities GMP documents. Ensure the safety and compliance of all applicable systems.

Wednesday to Saturday from 2200 to 0900

• Perform preventative, routine and corrective maintenance of CTU’s, process utility systems, and manufacturing/laboratory instruments.
• Understand calibration / metrology and calibrate, adjust, and maintain measuring and indicating instruments to conform to set standards.
• Understand PLC’s, HVAC, mechanical and electrical systems, and troubleshoot and repair.
• Perform routine inspections of the facility, equipment and systems.
• Monitor, investigate and respond to alarms generated from the BMS/QEMS.
• Know a wide range of standards, including temperature, relative humidity, differential pressure, CO₂, flow, conductivity, resistivity, speed, time, pressure, and weight.
• Support Metrology to investigate OOT events using root cause analysis, metrics, technical knowledge and historical experience to identify and remediate.
• Read and interpret engineering and architectural drawings, including floor plans, reflected ceiling plans, power plans, panel schedules, mechanical/plumbing piping diagrams, and Piping & Instrumentation Diagrams (P&IDs).
• Write incident/deviation reports as necessary, perform root cause analyses and identify corrective actions.
• Receive, filter and execute work order requests as necessary.
• Ensure equipment repairs or maintenance activities are compliant with applicable building codes.
• Work with external vendors for the service and/or repair of equipment.
• Provide “On‑Call” support as needed.
• 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.

• Bachelor’s degree with 5 years of experience / Associate’s Degree with 10 years of experience is required.
• 5-10 years of related instrumentation and equipment experience in a GMP environment is required.
• Experience using Computerized Maintenance Management Software (Blue Mountain) is required.
• Experience using Building Management Systems and Environmental Monitoring Systems (Siemens Desigo or Insight) is required.
• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE).
• Excellent oral and written communication skills are required.
• Must have a valid driver’s license.

• Prior experience in cell therapy manufacturing or Bio Pharma/Life Sciences is highly desirable.
• Experience working under ISO/IEC 17025 and/or ANSI/NCSL Z540.3 management systems is preferred.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations is preferred.

• Wear appropriate clean room attire and all Personal Protective Equipment (PPE).
• Meet requirements for and wear a half‑face respirator.
• Stand and/or walk 90% (and sit 10%) of a 10‑hr day which may include climbing ladders or steps.
• Crouch, bend, twist, reach, and perform activities with repetitive motions.
• Lift and…