Instrumentation and Equipment Specialist II-Wednesday to Saturday

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 realtime propose corrective solutions and complete and review related Facilities GMP documents. Ensure the safety and compliance of all applicable systems.

Shift:

Wednesday Saturday 10pm 9am

Essential Functions and Responsibilities

• Perform preventative routine and corrective maintenance of CTUs 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 PLCs 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 OnCall 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

• Bachelors degree with 5 years of experience / Associates Degree with 10 years of experience is required.
• 510 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 drivers 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 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 halfface respirator.
• Able to stand and/or walk 90 (and sit 10 of a 10hr 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 problemsolving analysis and discretion; ability to handle workrelated 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 individuals 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

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 ourCandidate Privacy Notice.

#LIonsite