Senior Quality Engineer - Consumables
Cellares
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South San Francisco, CA, USA
Posted on Tuesday, March 7, 2023
Position Summary
We are seeking an innovative and highly motivated Senior Quality Engineer who will be part of Cellares’ Quality group and contribute significantly to the development of our advanced cell therapy manufacturing platform by representing Quality in the design of Single Use Systems for the Cell Shuttle.
The primary focus of this position is to actively lead all aspects of Quality Engineering activities in an FDA-regulated environment and ensure compliance with 21 CFR 210, 211 cGMP and ISO 13485 requirements.
This is a multidisciplinary role and this individual will interface across many parts of the company (with scientists, researchers, and engineers). This person will lead and drive Quality throughout the product life cycle from product development and production builds to market release.
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.
Responsibility
- Working closely with the design team, this individual will be providing quality direction and guidance to the development and the design control processes.
- Define the quality assurance expectations for risk management, design planning strategies, ensure that each stage of the design and development is adequately documented, recorded and maintained
- Create quality documentation, protocols, reports, specifications, templates and developing procedures to ensure a systemic process for design and development, ensuring compliance with regulatory requirements throughout the development and the product life cycle
- Perform independent reviews of the product development life cycle deliverables; from the requirements gathering phase to the retirement phase
- Work collaboratively with cross functional teams to define a process and a set of documentation to support and verify the progress of the design and development activities. Manage and control the design and development while transferring it to manufacturing
- Ensure that all design changes are adequately reviewed, evaluated, approved and documented
- Review and approve documentation associated with planning, intended use, user requirements, hazard analysis, risk assessments, functional and design specifications, design reviews, test protocols, requirements trace matrix, Master Validation Plan, V&V packages along with support documentation for equipment and systems
- Collaborate with cross functional teams, including external parties to establish verification and validation plans for test methods, equipment, processes and products while using appropriate techniques and identification of risks through execution of FMEA and Risk Analysis
- Maintain design and development history files (DHF)
- Understand the single use systems design to facilitate participation in technical discussions and risk-based decision making
- Perform assessments on supplier capability to deliver quality products for single use systems to market and defining the associated technical tests
- Drive root cause analysis investigations and CAPAs and actively participate in continuous improvement activities with cross-functional teams
- Conduct quality audits
- Mentor and train junior level engineers
- Participate in regulatory inspections
- Establish and promote an environment that supports the Quality Policy, Data Integrity and Quality System
- Deep understanding of ISO 13485, ISO 14971, ISO 10993 ICH Q9 , 21CFR820, USP, 21 CFR Parts 210,211and part 11, EU Annex 1 requirements
Requirements
- Bachelor's degree or higher in Science, Engineering, or Quality Engineering
- 5+ years of related work experience in Quality Engineering or System Engineering
- Experience working in an FDA-regulated industry
- Knowledge of Design Assurance, preferably with automated manufacturing and computerized lab systems
- Experience working with complex single use systems
- Experience and Advanced knowledge of Sterility Assurance in impacting Product Quality
- Understanding of data integrity requirements and how to perform assessments
- Practical knowledge of 21 CFR Part 11 (electron records/electronic signature), 21 CFR Parts 210, 211, GAMP 5, 21 CFR Part 820 and ISO 14971 ISO 13485, ISO 10993
- Experience in supporting manufacturing of medical devices desired
- Must possess excellent organizational, clear verbal, and written communication skills
- High level of attention to detail and compliance and ability to effectively support multiple high priority deliverables at once
- Hands on approach, self-motivated with a passion for solving problems
- Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset
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.
This job is no longer accepting applications
See open jobs at Cellares.See open jobs similar to "Senior Quality Engineer - Consumables" Eclipse.