Computer System Validation Engineer (I, II, III)

Cellares is seeking an innovative and highly motivated Computer System Validation (CSV) Engineer to join their Quality group. This role will significantly contribute to the development of their advanced cell therapy manufacturing platform. The primary focus is to lead Quality Engineering activities in an FDA-regulated environment, ensuring compliance with cGMP, GAMP 5, and ISO 13485 requirements.

Key responsibilities include:

• Providing quality direction and guidance to development and design control processes
• Creating quality documentation, protocols, and reports
• Performing independent reviews of CSV deliverables
• Collaborating with cross-functional teams on design and development activities
• Reviewing documentation for planning, user requirements, risk assessments, and more
• Establishing verification and validation plans
• Driving root cause analysis investigations and CAPAs
• Conducting quality audits

The ideal candidate should have:

• A Bachelor's degree or higher in Science, Engineering, or Software discipline
• 3+ years of experience in Software Quality Engineering and CSV
• Experience in FDA-regulated industries
• Knowledge of Software development life cycles
• Understanding of data integrity requirements
• Practical knowledge of relevant regulations and standards

Cellares offers a competitive compensation package, including base salary, stock options, and comprehensive benefits. The company is headquartered in South San Francisco, California, with a commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. Backed by world-class investors, Cellares has raised over $355 million in financing.

Join Cellares in their mission to accelerate access to life-saving cell therapies and make a significant impact in the field of cell therapy manufacturing.