3DBio Therapeutics is a biologics and bioprinting company with a focus on regenerative medicine that precision manufactures living tissues to allow the 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 and 3DBio is currently in clinical Phase 1/2a.

The Process Engineer Associate will be responsible for the performance of manufacturing and materials processing for development, pilot, and cGMP medical device manufacturing in accordance with well-defined standards and procedures. This individual will be expected to actively participate within the team and assist in creating a positive work environment. This individual may also provide support to other groups such as Quality Control, Quality Assurance, and Research.

This position will support both Operations and Development and work closely with other key stakeholders including Quality to perform and document manufacturing processes, support cGMP facility operations and upkeep and maintain cGMP compliance. The ideal candidate will be hardworking, efficient, flexible, and able to perform key responsibilities in a fast-paced, team environment.

0 - 2 years of medical device or aseptic biopharmaceutical manufacturing experience is preferred. Depending upon experience and ability to learn new tasks, the engineering associate will be trained in areas that may include medical device design/fabrication, bioprocessing procedures, analytical equipment use and results interpretation, and/or overall CNC MFG and cleanroom support. The primary role is to perform clinical production activities that include extended hours of processing activities while standing and gowned inside the clean rooms.

Responsibilities:

  • Perform internal manufacturing, testing, labeling and packaging of intermediates. Serve as the primary operator or as the secondary verifier.
  • Ensure clear, documentation of all activities in accordance with current Good Manufacturing Practices to comply with regulatory requirements.
  • Participate in batch record review as required by Quality and Production management
  • Identify any issues and escalate to leadership and Quality Assurance. Work with leadership and team to address issues in a timely fashion.
  • Desire to gain a deep knowledge of medical device production processes as well as a basic understanding of cGMP requirements, rules, and regulations
  • Serves as a technical contributor for process-related issues and investigations at the laboratory
  • Executes experimental procedures as detailed in developmental protocols
  • Assists in documenting changes/updates to processing policies and procedures.
  • Provide support for manufacturing facility development, buildout, commissioning, and qualification activities.
  • Assist to define, deploy, start-up and support medical device manufacturing equipment
  • Work with senior process engineers on maintenance and upgrade of existing products/processes
  • Maintain the laboratory in a safe, clean, and orderly manner.
  • Dispose of and work alongside chemical and biohazardous material.
  • Support operations and development in performing equipment calibration, certification, and qualification, as appropriate, and maintain compliance with systems.
  • Work with the Quality organizations as necessary to help investigate any excursions, deviations, CAPAs, etc and develop appropriate corrections.
  • Stay current with company SOPs, batch records and industry standards, and all applicable regulations.

Job Requirements

  • 0 - 2 years of medical device manufacturing experience is preferred
  • Prior medical device manufacturing, 3D printing, and/or Engineering academic lab experience is preferred
  • Bachelor’s degree in Biomedical, Mechanical engineering or equivalent preferred.
  • Attention to detail and ability to follow clear written documentation.
  • Competency with Microsoft Office (Word/Excel)
  • Requires some heavy lifting, moderate levels of standing, and is physically demanding.
  • Requires legible handwriting and good eye-hand coordination skills.
  • Ability to perform manual processes that require high-level dexterity and repetitive motions.
  • Comfortable spending several hours in our ISO8 cleanroom gowned.
  • Strong ethical foundation.
  • Experience with the manufacturing of Advanced Technology Medicinal Products preferred.