Facilities Engineering Manager

1 month ago

Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time
Job Summary

We are seeking a highly skilled Facilities Engineering Manager to oversee the technical facilities and plant engineering teams responsible for supporting maintenance and metrology functions at multiple Iovance GMP facilities.

The successful candidate will provide project engineering and project management support for mid-to-large capital expenditure construction/fit-out projects, coordinating with maintenance, metrology, process engineering, operations, supply chain, and quality teams to ensure maximum uptime and efficiency of all systems and equipment.

Key Responsibilities:

  • Support the installation, start-up, commissioning, and qualification of facilities equipment, systems, and utilities associated with cGMP manufacturing, laboratories, and warehouses.
  • Develop and implement reliability and predictive maintenance programs to increase uptime and address equipment problems affecting the manufacturing process.
  • Provide technical and engineering expertise and support to all departments as needed, including monitoring and responding to alarms generated from building management systems and quality management systems.
  • Lead critical-level investigations related to facilities alarms and deviations, approving deviations, non-conformances, and CAPAs as required, in partnership with quality to address these issues effectively and compliantly.
  • Develop and continuously improve departmental standard operating procedures.
  • Independently apply advanced engineering techniques and analysis, providing technical guidance to less experienced design and engineering personnel.

Requirements:

  • BS or MS in an engineering field is required, or equivalent experience.
  • 10 to 15 years of related bio-pharma/life sciences experience is required.
  • Comprehensive understanding of principles, theories, concepts, and industry practices and standards, and their application.
  • Extensive knowledge of small-scale cell culture processes and techniques is preferred.
  • Experience interfacing with other design disciplines, including automation, facility design, and mechanical design groups, is required.
  • Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations, is required.
  • Ability to wear appropriate clean room attire and all personal protective equipment (PPE), including scrubs, gowning coverall, masks, gloves, etc.
  • Experience interfacing with CQV and operations teams is required.
  • Experience in scheduling and budgeting facilities and process engineering efforts is highly desirable.
  • Experience using computerized maintenance management software (Blue Mountain) and building management systems (Siemens - Apogee/Desigo) and environmental monitoring systems is required.
  • Demonstrable experience on cGMP capital, maintenance, and operating projects is required.
  • Excellent oral and written communication skills are required.

Preferred Requirements:

  • Prior experience in cell therapy manufacturing is highly desirable.

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