Instrumentation & Equipment Specialist II (3rd Shift Sunday - Wednesday, 10:00pm - 8:30am)
About The Position
The Instrumentation and Equipment Specialist II is responsible for maintaining, calibrating, and repairing equipment, utilities, and systems that support cGMP manufacturing, laboratories, and warehouse operations. The role performs planned and corrective maintenance and calibration according to written instructions, diagnoses field issues in real time, proposes corrective solutions, and completes and reviews related Facilities GMP documents. The specialist helps ensure the safety and compliance of applicable systems. This is a third-shift position scheduled Sunday through Wednesday, 10:00 p.m. to 9:00 a.m. The position works in both an office and a manufacturing lab setting, including cleanroom environments.
Requirements
- Bachelor’s degree and 5 years of experience, or an associate degree and 10 years of experience.
- 5–10 years of related instrumentation and equipment experience in a GMP environment.
- Experience using Computerized Maintenance Management Software (Blue Mountain).
- Experience using Building Management Systems and Environmental Monitoring Systems, such as Siemens Desigo or Insight.
- Ability to wear appropriate cleanroom attire and all required PPE, including scrubs, gowning coveralls, masks, and gloves.
- Excellent oral and written communication skills.
- Valid driver’s license.
- Ability to meet the physical demands of the role, including standing and/or walking for most of a 10-hour day, climbing ladders or steps, crouching, bending, twisting, reaching, performing repetitive motions, and lifting and carrying objects weighing up to 45 pounds.
- Ability to meet requirements for and wear a half-face respirator.
Nice To Haves
- Understanding of calibration/metrology and the ability to calibrate, adjust, and maintain measuring and indicating instruments to conform to set standards.
- Understanding of PLCs, HVAC, mechanical, and electrical systems, with troubleshooting and repair ability.
- Knowledge of standards for temperature, relative humidity, differential pressure, CO2, flow, conductivity, resistivity, speed, time, pressure, and weight.
- Prior experience in cell therapy manufacturing or BioPharma/Life Sciences.
- Experience working under ISO/IEC 17025 and/or ANSI/NCSL Z540.3 management systems.
- Quality mindset and familiarity with 21 CFR Part 11, standard GxP best practices, and FDA regulations.
Responsibilities
- Perform preventative, routine, and corrective maintenance of CTUs, process utility systems, and manufacturing and laboratory instruments.
- Perform routine inspections of the facility, equipment, and systems.
- Monitor, investigate, and respond to alarms generated from the BMS/QEMS.
- Support Metrology in investigating out-of-tolerance events using root cause analysis, metrics, technical knowledge, and historical experience to identify and remediate issues.
- Read and interpret engineering and architectural drawings, including floor plans, reflected ceiling plans, power plans, panel schedules, mechanical/plumbing piping diagrams, and P&IDs.
- Write incident and deviation reports as necessary, perform root cause analyses, and identify appropriate corrective actions.
- Receive, filter, and execute work order requests as necessary.
- Ensure equipment repairs and maintenance activities comply with applicable building codes.
- Work with external vendors to service and/or repair equipment.
- Provide on-call support as needed.
- Adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Comply with Safety SOPs, SDS sheets, and laboratory procedures in accordance with company policy and OSHA regulations.
- Perform miscellaneous duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
