We are seeking a Systems Engineer to develop, execute, and manage system verification and validation plans for a high-throughput QC testing platform utilizing innovative lab automation. This role will also collaborate on the incremental development and optimization of scalable, robust, end-to-end automated solutions.
The successful candidate will work closely with cross-functional teams to refine system designs, troubleshoot issues, and lead continuous improvement projects.
The ideal candidate will have a proven ability to collaborate and communicate effectively across functions, along with strong hands-on experience in previous roles.
Candidates should enjoy working in a fast-paced, mission-driven environment and be prepared to tackle a broad selection of challenges as the company grows.
Responsibilities
- Collaborate with cross-functional teams to develop integration plans, conduct verification testing, troubleshoot issues, investigate root causes, and drive continuous improvement of automated QC testing platforms
- Monitor system performance, track recurring issues, and work with engineering and quality teams to implement technical and procedural improvements
- Analyze automated workflows to identify bottlenecks and areas for optimization
- Author technical documents, procedures, and reports
- Lead the creation and implementation of FMEAs and risk assessment methodologies to identify and mitigate potential failure points in automated systems
Requirements
- Bachelor's or higher degree in Engineering, Biotechnology, or a related field
- 5+ years of experience designing, testing, and implementing laboratory automation systems
- Experience with laboratory analytical instruments and automated systems
- Extensive hands-on experience with integration testing and troubleshooting in the integration of analytical instrumentation
- Familiarity with DoE (Design of Experiments) principles and best practices
- Familiarity in Systems Engineering best practices
- Strong technical writing skills and experience authoring Standard Operating Procedures (SOPs), documentation, and training materials
- Experience in programming languages such as Python or C#
- Excellent problem-solving skills and the ability to troubleshoot technical issues
- Familiarity with FMEAs and risk assessment methodologies
- Strong communication skills to collaborate effectively with cross-functional teams
- Attention to detail and the ability to work independently and manage multiple tasks simultaneously
- Creative, self-motivated, eager to take on a wide variety of tasks and grow with the evolving technology
- Self-awareness, integrity, authenticity, and a growth mindset
Cellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent.
This is Cellares
Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.
The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.
Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.
Top Skills
What We Do
Cellares is revolutionizing cell therapy manufacturing. We are developing a one-of-a-kind solution, The Cell Shuttle, to overcome the challenges associated with manufacturing so these life-saving therapies are affordable and widely available to patients who can benefit.
The clinical impact of cell therapy in treating cancer has been proven, but this therapeutic approach has several limitations, especially in manufacturing, leaving extremely sick patients waiting for treatment and desperate for hope.
Since cell therapy is currently produced for a single patient at a time, it is expensive to manufacture, requiring significant time and resources, and is difficult to scale.
Preclinical and clinical scientists, as well as commercial cell therapy manufacturers also lack the options to fully automate their manufacturing process quickly, safely, cost-effectively and at the scale they need.
The Cell Shuttle is an automated and closed end-to-end manufacturing solution that is flexible and scalable, enabling customers to run exact processes specified for their cell therapy. Compared with the current manual manufacturing processes for cell therapy, the Cell Shuttle’s next-generation automated manufacturing solution has 10 times the scalability (meaning 10 times more patient doses can be produced simultaneously), enables a three-fold reduction in process failure rates and will reduce the per-patient manufacturing cost by up to 70 percent for most processes.
