Facilities Engineer I

3DBio Therapeutics is a biologics and bioprinting company with a focus on regenerative medicine that precision manufactures living tissues to allow replacement of each individual patient’s parts with tissues designed and created specifically for them. 3DBio has developed unique capabilities toward the creation of living tissue implants for therapeutic applications. The technology platforms include a full suite of features to meet the FDA’s requirements for therapeutic manufacturing, including novel and proprietary: 3D-bioprinter (GMPrint™), bio-ink (ColVivo™), and cell processes. In pre-clinical studies the platform has demonstrated the ability to generate functioning living tissues.

Requirements and Responsibilities:

The Facilities Engineer I will be responsible for supporting smooth, everyday operations that quickly require adaptive responses to both regular and unforeseen challenges. The breadth of this role covers a vast array of activities, with the primary focus centering in on equipment and instrumentation reliability, facility upkeep, and utilities attentiveness. Activities vary and include taking action when our automated monitoring system alarms, receiving compressed gas/liquid and clean room garment deliveries, awareness of electrical circuits and associated demand requirements, and orchestrating upcoming calibrations/certifications/requalifications/revalidations. Improvements of handling these items is expected over time, including instituting/revising procedures and analyzing data collection for best approaches. Following a standard format and in some cases templates, recurring validation protocols and reports will be generated.

This role entails responsibility for the first floor of our facility which is approximately 2,500 square feet that’s compromised of a roughly 900 square foot clean room, 1500 square foot lab area, and receiving area/hallway rounding out the rest. There are plans to expand the facility towards the end of 2020. This position will serve as secondary support for that construction. The elected candidate will provide regular updates to Senior Management on major happenings and crucial facility projects/timelines. Trade contractors and equipment vendors will also be escorted/managed as appropriate throughout the facility, with a firm knowledge of the scope of work for these visitors.

The Facilities Engineer I must be both a creative and analytical thinker. This individual should have strong communication and management skills, as well as the ability to work with and motivate inter-departmental teams. Other departments will view themselves as a customer to this position, so attentiveness to needs and prioritization is essential. Often times, this will require conferring with Senior Management on overall priorities. The ability to take initiative and work independently is expected, as well as a familiarity with time-sensitive pursuit pressures of an expanding company.

Effective oral and written communication while maintaining accurate/detailed documentation is required.

Job Requirements

  • A minimum of 2 years of experience within Biotech/Pharma operations or cGMP facility contributions within a production or research site is required. It’s preferred that the candidate has 5-10 years of the above experience with prior exposure to calibration, validation, production machinery, and analytical instrumentation.
  • Bachelor’s degree in Life Science or Engineering (or pursing) is preferred. High School Diploma or Equivalent allowed with more than 5 years of relevant experience
  • Attention to detail and ability to follow clear written documentation.
  • Use of basic computer software such as Microsoft Office, Excel, Project. Visio a plus
  • Requires some heavy lifting when deliveries arrive and moderate levels of standing.
  • Strong ethical foundation
  • Experience with supporting aseptic manufacturing of Advanced Technology Medicinal Products preferred.