Synthego is enabling genome engineering at scale with a blend of scientific instrumentation, industrial automation, and data science. Our team of scientists and engineers are putting multidisciplinary fields together to solve problems that no one field can tackle alone.
We are searching for an innovative Production Process Engineer to own the transfer of new products and equipment into our automated laboratory operation. With a focus on the successful introduction and adoption of new platforms in operations, this role will collaborate closely with systems engineering, software development, research, and production. The ideal candidate is well-versed in lean manufacturing, visual management, and has experience working with mammalian cell editing and culture. This position requires the tact to mentor, train, and develop others, as well as the sense of urgency and willingness to get hands-on to support the production team when necessary.
What You'll Do
Work directly with site Engineering teams to draft V&V documents, own transfer process to operations, and optimize utilization of new laboratory equipment, automation and protocols
Partner with Development teams to ensure new technologies are robust, address the needs of production, and take into account human factors and minimal downtime.
Initiate and drive Change Controls as they relate to technology transfer, process changes, and/or improvements. Present to Change Control Review Board and leverage cross-functional resources for phase gate approvals.
Develop equipment documents and collaborate with Factory Service Engineering to ensure maintenance and service needs are appropriately captured, scheduled, and periodically reviewed.
Leverage lean tools, such as value stream mapping and gemba walks, to identify bottlenecks and implement solutions to streamline production.
Design innovative solutions to improve operational safety, quality, efficiency, delivery, and costs
Coordinate with Systems Engineering and Quality to ensure the seamless transfer of new products and processes into production, including all required SOP's and training records
Participate in the site audit program, ensuring compliance to all published procedures. Serve as Subject Matter Expert (SME) for all Production related equipment and systems.
Initiate and investigate non-conformances as they relate to the Production equipment, process, or systems. Facilitate cross-functional root cause investigation, author investigation summary, implement CAPAs, and effectiveness checks.
Work with engineering and equipment vendors to design, procure, install, and validate new measurement and control systems.
Provide solutions for process control strategies, analytical data tools, and data/system models and implement into production processes
Author and maintain production work instructions
3+ years experience optimizing production operations in regulated industry environment.
Strong understanding of process control, aseptic technique, DNA sequencing, and cell culture
Strong understanding of laboratory best practices, continuous improvement methodologies, and lean manufacturing principles, including 5S, Gemba, and Kaizen
Experience with formal quality management systems required
Innovative, motivated, and independent leader with proven ability to work cross-functionally and drive accountability.
Excellent interpersonal skills
Company Benefits & Perks
4x Daily shuttle to and from San Francisco (more locations to come)
Generous equity at an early stage company
Fully stocked kitchen and snacks
Catered lunch and dinner
Synthego's vision is to turn biology into an information science, with the ultimate goal of dramatically extending the healthy human lifespan.
Synthego builds advanced bioinformatics and automated hardware platforms to create next-generation molecular biology tools, starting with full-stack genome engineering.
These world-class tools accelerate basic scientific discovery, critical disease cures and novel synthetic biology applications to improve and prolong life.