Overview

The Metrology Specialist is responsible for calibrating and repairing equipment and systems supporting cGMP Manufacturing, Laboratories, and Warehouse. Perform calibrations using appropriate procedures and standards for various utilities, equipment, and instruments.

Essential Functions and Responsibilities

• Calibrate, adjust, and maintain measuring and indicating instruments to meet set standards. Some calibrations will be performed in a clean room environment.
• Understand a wide range of standards, including temperature, relative humidity, differential pressure, CO2, flow, conductivity, resistivity, speed, time, pressure, and weight.
• Assist in investigating OOT events using root cause analysis, metrics, technical knowledge, and historical experience to identify and remediate.
• Support deviations and change controls related to OOTs.
• Assist in maintaining calibration standards.
• Ability to read and interpret engineering and architectural drawings, including floor plans, reflected ceiling plans, power plans, panel schedules, Piping & Instrumentation Diagrams (P&IDs)
• Receive, filter, and execute work order requests as necessary.
• Assist with preventive and corrective maintenance activities and ensure that any repairs or maintenance activities are compliant with the manufacturer’s recommendations.
• Work from established calibration procedures.
• Ensure current Good Manufacturing Practices (cGMP) and change control procedures are followed.
• Work with external vendors for the calibration, service and/or repair of equipment.
• Assist investigating problems and diagnosing and repairing
• Work in a cleanroom with biohazards, human blood components, and chemicals
• 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

• Minimum B.S. degree with 0 – 1 years of industry experience, or A.A. degree with 1-2 years of industry experience, or GED with 3 – 5 years of industry experience.
• 0 - 1 years of Metrology and Calibration experience required. Prior experience in cell therapy manufacturing or BioPharma/Life Sciences is highly desirable.
• Certification from an accredited body, ASQ CCT Certification or equivalent, is required (within 1 year of hire)
• Experience working under ISO/IEC 17025 and/or ANSI/NCSL Z540.3 management systems is preferred.
• Direct experience with calibrating and maintaining equipment in a regulated environment is preferred.
• Experience using Computerized Maintenance Management Software (Blue Mountain) is preferred.
• Experience using Environmental Monitoring Systems (Siemens Desigo or Insight) is preferred.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations is preferred.
• Excellent oral and written communication skills required.
• Must have a valid driver’s license.

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 cleanroom attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coveralls, 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 the scheduled workday 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 deadlines.

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 a Lab setting with various chemical/biochemical exposures, including latex and bleach, and 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 careers@iovance.com.

 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. 

#LI-onsite