Consumable Qualification Engineer (I, II, III)

First Integrated Development and Manufacturing Organization (IDMO) taking an Industry 4.0 approach to mass manufacturing cell therapies.
$90,000 - $210,000
Backend
Senior Software Engineer
In-Person
10+ years of experience
Healthcare · Biotech

Description For Consumable Qualification Engineer (I, II, III)

Cellares, the pioneering Integrated Development and Manufacturing Organization (IDMO), is revolutionizing cell therapy manufacturing with their Industry 4.0 approach. They are seeking a Consumable Qualification Engineer to join their team in South San Francisco. This role is crucial for ensuring the safety and compliance of consumables used in advanced medical and pharmaceutical applications.

The position involves leading testing and validation efforts in compliance with ISO 10993, USP Class VI, and other regulatory standards. You'll work closely with various teams including Systems Engineering, R&D, Mechanical Engineering, Quality, and Manufacturing. The role requires expertise in biocompatibility testing, extractables and leachables analysis, and sterilization validation.

Cellares offers a competitive compensation package ranging from $90,000 to $210,000 annually, along with comprehensive benefits including medical coverage, 401(k) matching, and stock options. The company has raised over $355 million in funding and operates a commercial-scale IDMO Smart Factory in Bridgewater, New Jersey.

This is an excellent opportunity for experienced professionals who thrive in a fast-paced, mission-driven environment and want to contribute to advancing cell therapy manufacturing. The role offers the chance to work with cutting-edge technology while making a significant impact on the accessibility of life-saving cell therapies.

Last updated 8 minutes ago

Responsibilities For Consumable Qualification Engineer (I, II, III)

  • 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 to support the integration of consumables into products
  • Analyze test results and produce clear, detailed technical reports, protocols, and documentation
  • Present findings to stakeholders and support continuous improvement initiatives

Requirements For Consumable Qualification Engineer (I, II, III)

  • 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

Benefits For Consumable Qualification Engineer (I, II, III)

401k
Medical Insurance
Dental Insurance
Vision Insurance
Equity
  • Competitive base salaries
  • Highly subsidized Medical, Dental, and Vision Plans
  • 401(k) Matching
  • Free EV Charging
  • Onsite lunches
  • Stock options

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