Instrumentation & Equipment Specialist II

Iovance Biotherapeutics, Inc.; Philadelphia (Philadelphia County); On-site; USD 85,000 - 105,000; Full time

Job summary

Iovance Biotherapeutics, Inc. is seeking an Instrumentation and Equipment Specialist II to maintain, calibrate, and repair equipment and systems across cGMP manufacturing, laboratories, and warehouses.

You will diagnose issues, implement corrective actions, and ensure safety and compliance with applicable SOPs and regulations. Responsibilities include preventive and corrective maintenance of CTUs and process utilities, calibrations to metrology standards, and collaboration with external vendors.

Qualifications

• Bachelor’s degree with 5+ years of GMP instrumentation experience.
• 5–10 years of related instrumentation and equipment experience in a GMP environment.
• Experience using Blue Mountain CMMS (CMMS software).
• Experience using Building Management Systems (Siemens Desigo or Insight).
• Must wear appropriate PPE and maintain cleanroom attire.
• Excellent oral and written communication skills.
• Must have valid driver’s license.

Responsibilities

• Perform preventative, routine and corrective maintenance of CTU’s, process utility systems, and manufacturing/laboratory instruments.
• Calibrate, adjust, and maintain measuring and indicating instruments to set standards.
• Troubleshoot PLCs, HVAC, mechanical and electrical systems and perform repairs.
• Perform routine facility inspections and monitor alarms from the BMS/QEMS.
• Ensure compliance with building codes during repairs and maintenance.
• Coordinate with external vendors for service/repair of equipment.

Skills

Communication skills

Valid driver’s license

Troubleshooting

Analytical thinking

Education

Bachelor’s degree

Associate degree

Tools

Blue Mountain CMMS

Siemens Desigo

Siemens Insight

Job description

About IovanceBiotherapeutics, Inc.

Iovance Biotherapeutics, Inc. isthe global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the firstFDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The Iovance TIL platform spans registrational trials and next-generation programs inadditionalalsolid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralizedU.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. For more information, please visit www.iovance.com.

Amtagvi® and its accompanying design marks,Proleukin®,Iovance®, and IovanceCares™are trademarks and registered trademarks ofIovance Biotherapeutics, Inc.or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.

Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com.

Overview

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.

Essential Functions and Responsibilities

• Perform preventative, routine and corrective maintenance of CTU’s, process utility systems, and manufacturing/laboratory instruments.
• An understanding of calibration / metrology and the ability to calibrate, adjust, and maintain measuring and indicating instruments to conform to set standards is highly desirable.
• An understanding of PLC’s, HVAC, mechanical and electrical systems, and be able to troubleshoot and repair is highly desirable.
• Perform routine inspections of the facility, equipment and systems.
• Monitor, investigate and respond to alarms generated from the BMS/QEMS.
• 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 is highly desirable.
• Support Metrology to investigate OOT events using root cause analysis, metrics, technical knowledge and historical experience to identify and remediate.
• 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)
• Write incident/deviation reports as necessary, perform root cause analyses and identify corrective actions as appropriate.
• Receive, filter and execute work order requests as necessary.
• Ensure that any equipment repairs or maintenance activities are compliant with any applicable building codes.
• Work with external vendors for the service and/or repair of equipment.
• Provide “On-Call” support as needed.
• 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

• Bachelor’s degree with 5 years of experience / Associates 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), i.e. scrubs, gowning coverall, masks, gloves, etc.
• Excellent oral and written communication skills required.
• Must have valid driver’s license

Preferred Education, Skills, and Knowledge

• Prior experience in cell therapy manufacturing or BioPharma/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.

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.

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.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact [e-mail].

By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.