Metrology Specialist I
Iovance Biotherapeutics
- Philadelphia, PA
- Permanent
- Full-time
- 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.
- 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.
- 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.