OverviewThe 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.
Shift: Wednesday to Saturday from 2200 to 0900Essential 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.
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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.
