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 preclinical studies, the platform has demonstrated the ability to generate functioning living tissues and 3DBio is currently in clinical Phase 1/2a.
The Manufacturing Engineer will be responsible for the performance of equipment used in manufacturing, materials processing, and general testing for development, pilot, and cGMP aseptic and device manufacturing in accordance with well-defined standards and procedures. This individual will 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 equipment validation/qualification, equipment procurement, and maintain cGMP compliance.
- Manage and supervise the activities of the facilities maintenance staff and third-party vendors to maintain a reliable, secure, and compliant site
- Oversee the performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality
- Work with Manufacturing and Quality personnel to define preventative maintenance and calibration programs (including spare inventories, frequency, timing, etc) for existing and new assets. May require the use of criticality assessments and FMEAs in concert with the Process Engineering staff.
- Manage staff and coordinate Facility shutdowns to ensure all PMs and repairs are completed in a timely manner, including all necessary documentation.
- Develop and oversee validation strategies and policies including validation documentation and protocols (IOQ, PQ, component assessments)
- Act as system owner and administrator for equipment data monitoring system. Fields alarms, onboards new equipment, develop procedures, train users, and maintain the alarm system.
- Lead, investigate, and collaborate with cross-functional stakeholders regarding quality systems, including quality events, deviations, CAPAs, change controls, and risk assessments
- Stay current with company and industry standards, and all applicable regulations.
- Create, revise, and review controlled documents including Standard Operating Procedures (SOPs) and logs for equipment
- Build effective cross-functional relationships with R&D and Quality and within the clinical manufacturing team
- BS in Chemical/Mechanical/Electrical/Industrial Engineering with 5 years in an aseptic biopharmaceutical or medical device environment
- 3+ years in a cGMP environment with an excellent understanding of federal regulations for Quality Systems (21CFR820) and cGMP manufacturing (21CFR 210,211)
- Validation Experience (IQ,OQ,PQ)
- Strong technical knowledge in lab systems and knowledge of cGMP requirements as they relate to the lab environment.
- Experience working in a cleanroom environment
- Self-starter and able to work with minimal supervision