Senior Quality Engineer

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 and proprietary consumables. 

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 cGMP and ISO 13485 requirements. 

This is a multidisciplinary role and this individual will interface across many parts of the company (with scientists, researchers, manufacturers, and engineers) and will lead and drive Quality throughout the platform and consumable life cycle from development to production builds to be utilized for GMP drug product manufacturing. 

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. 

• Working closely with the Engineering design team, providing quality direction and guidance to the development and the design control processes, defining the quality assurance expectations for risk management and design planning strategies and ensuring that each stage of the design and development is adequately documented, recorded and maintained
• Overseeing design quality system records such as protocols, reports, specifications, drawings, bill of materials, risk assessment documents and developing procedures to ensure a systematic process for design and development, ensuring compliance with regulatory requirements throughout the platform and consumables life cycle
• Collaborating with cross-functional teams to establish consumable qualification strategies and review/approve qualification protocols and reports
• Generating and owning program level SOPs for the engineering design control program
• Performing independent reviews of the product development life cycle deliverables, from the requirements gathering phase to the retirement phase
• Working 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 and for managing and controlling the design and development and its eventual design transfer to manufacturers 
• Ensuring that all design changes are adequately reviewed, evaluated, approved and documented
• Reviewing and approving documentation associated with planning, intended use, user requirements, hazard analysis, risk assessments, functional and design specifications, design reviews, test protocols, test reports, V&V packages along with support documentation for the platform and consumables
• Collaborating with cross functional teams, including external parties to establish test methods using appropriate techniques and identification of risks through execution of FMEA and Risk Analysis
• Maintaining design and development history files (DHF)
• Reviewing and approving software changes to existing systems from a Quality Engineering perspective ensuring changes are implemented in compliance with internal procedures and requirements as well as external standards
• Providing guidance, strategy and approvals in the implementation of approved design control changes into Cellares’ GMP facilities.
• Participating in quality audits and regulatory inspections as needed
• Mentoring and training junior level engineers 
• Promoting an environment that supports the Quality Policy, Data Integrity and Quality System

• Bachelor's level degree or higher in Science, Engineering, or Quality Engineering
• 5-7 years of related work experience in Quality Engineering
• Experience working in an FDA-regulated industry
• Knowledge of System development life cycles (SDLC) and Design Assurance, preferably with automated manufacturing and computerized lab systems
• 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
• Familiarity with consumable qualification requirements including biocompatibility standards (ISO 10993), extractables/leachables testing principles, sterilization validation (ISO 11137), and supplier qualification processes in regulated industries
• 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.