We are seeking a hands-on Consumable Qualification Engineer to lead the testing and validation of consumables in compliance with ISO 10993, USP Class VI, and other relevant regulatory standards. This role works closely with Systems Engineering, R&D, Mechanical Engineering, Quality, and Manufacturing teams to ensure consumables are safe, compliant, and effective for use in advanced medical and pharmaceutical applications.
Your primary responsibility will be to drive the qualification of consumables by designing and executing testing plans for biocompatibility, extractables and leachables, distribution, container closure integrity, sterilization validation, and microbial ingress. The role requires managing relationships with external labs and ensuring that tests are completed accurately and efficiently.
This is a multidisciplinary role & this individual will interface across many parts of the company. 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
- Develop and lead qualification plans for consumables, ensuring compliance with regulatory standards (ISO 10993, USP Class VI)
- Design and execute tests, including biocompatibility, extractables and leachables, container closure integrity, sterilization validation, microbial ingress, and distribution testing
- Coordinate with external labs for execution of testing, ensuring accuracy and timeliness
- Collaborate across departments, including Systems Engineering, R&D, Mechanical Engineering, Quality, and Manufacturing, to support the integration of consumables into products
- Analyze test results and produce clear, detailed technical reports, protocols, and documentation
- Present findings to both technical and non-technical stakeholders and support continuous improvement initiatives in consumable qualification processes
Requirements
- BS/MS in Bioengineering, Chemical Engineering, or Material Science with 10+ years of relevant industry experience, or PhD with 7+ years
- Deep understanding of ISO 10993, USP Class VI, and other biocompatibility standards
- Hands-on experience with qualification testing for biocompatibility, extractables and leachables, sterilization, and other critical consumable tests
- Proven ability to manage external lab relationships for testing purposes
- Strong communication skills for preparing technical reports and collaborating with cross-functional teams
- Familiarity with the medical device and pharmaceutical industries, particularly around regulatory requirements
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.
