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.
The Process Engineer will be responsible for the development and scale up of internal manufacturing processes to support the growth and advancement of 3D Bio’s regenerative medicine products.
This position will work closely with key stakeholders including Development, Quality, Manufacturing and external manufacturers to develop and scale processes, equipment and packaging in support of 3D Bio’s regenerative medicine products.
- Lead contributor in late stage process development for transferring new products and processes to manufacturing
- Selection of appropriate components and equipment based on analysis of specifications reliability and regulatory requirements
- Identify, implement and develop equipment to support scale up of internal manufacturing of medical devices.
- Analyze equipment to establish operating data, conduct experimental test and result analysis.
- Ensure that all activities are completed and documented in accordance with procedures
- Support investigations as required
- Assist in resolving technical issues with equipment and production processes
- Support development of systems for equipment calibration, certification and qualification and ensure compliance with systems, including MSA studies.
- Participate in PFMEA and other process risk based process evaluations.
- Designing and executing equipment and process qualifications and validation studies and implementation of new processes and products.
- Drafting equipment and materials specification, operating SOPs, Work Instruction and provide training for manufacturing team members.
- Capable of generating and maintaining system life cycle documentation (Drawings, Design Files, etc)
- Ensure quality of process and product as defined in the appropriate equipment operation and material specifications
- Support manufacturing facility development, buildout, commissioning and qualification.
- Support development of relevant manufacturing metrics, data collection, reporting and process improvements.
- Support the development of regulatory CMC documentation.
- Work with the Quality organizations as necessary to help investigate any excursions, deviations, CAPAs, etc and develop appropriate corrections.
- B.S. Degree in biomedical engineering, mechanical engineering, or similar related field required.
- A minimum of 5 years in medical device manufacturing engineering / development required.
- Knowledge of FDA, GMP and ICH requirements
- Proven experience in improving quality and scaling up / out manufacturing processes and systems to support medical device development.
- Experience with process development for medical devices and/or Advanced Technology Medicinal Products preferred.
- Strong communication skills with the ability to effectively work cross-functionally and externally as required.