Facilities Engineering Manager

1 day ago


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

We are seeking a highly skilled Facilities Engineering Manager to join our team at Iovance Biotherapeutics Inc. This role will be responsible for overseeing the technical facilities and plant engineering teams, ensuring maximum uptime and efficiency of all systems and equipment.

Key Responsibilities
  • Provide project engineering and project management support for mid-large CapEx construction/fit-out projects.
  • Coordinate with the Maintenance, Metrology, Process Engineering, Operations, Supply Chain, and Quality teams to ensure seamless operations.
  • Support the installation, start-up, commissioning, and qualification of facilities equipment, systems, and utilities associated with cGMP manufacturing, laboratories, and warehouses.
  • Develop and collaborate on reliability and predictive maintenance programs to increase uptime and address equipment problems.
  • Provide technical and engineering expertise and support to all departments as needed.
  • Monitor and respond to alarms generated from the BMS/QEMS, including off-hours and weekends.
  • Lead critical level investigations related to facilities alarms and deviations, and approve deviations, non-conformances, and CAPAs as required.
Requirements
  • BS or MS in an Engineering field is required, or equivalent experience.
  • 10 to 15 years of related BioPharma/Life Sciences experience is required.
  • Comprehensive understanding of principles, theories, concepts, and industry practices and standards is required.
  • Extensive knowledge of small-scale cell culture processes and techniques is preferred.
  • Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations is required.
  • Ability to work in a lab setting with various chemical/biochemical exposures, including latex and bleach.
  • Ability to work in a cleanroom with biohazards, human blood components, and chemicals.
Work Environment

This position will work in both an office and a manufacturing lab setting. The ability to work in a fast-paced environment with multiple priorities and deadlines is essential.

Iovance Biotherapeutics Inc is an equal-opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity, equity, and inclusion.


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