Bio-manufacturing Quality Engineer

about 3 years ago
Full time role
Redwood City, CA, US... more
Redwood City, CA, US... more

Job Description

Impossible Foods is addressing the most catastrophic threats facing humanity: climate change and biodiversity collapse. A global transition to a plant-based food system will turn back the clock on atmospheric CO2 levels, restore natural ecosystems and reverse meltdown in wildlife biomass.
The easiest -- if not only -- way to make our civilization sustainable is to eliminate livestock, the most dangerous technology on Earth. But humans won’t give up meat. So we need to make meat better -- more delicious and more nutritious, without animals as the underlying production technology. That means that making meat sustainably is the most important and urgent problem for the global scientific community.
Impossible Foods' mission is to completely replace the use of animals as a food-production technology by offering consumers everything they currently value about animal products -- and making products that are vastly superior to their animal analogues.
To do this, we are taking a revolutionary scientific and market-based approach. We are inventing efficient, sustainable ways to transform ingredients from plants into meat, fish and dairy foods that deliver all the pleasures and nutritional benefits consumers demand, without the destructive environmental or public health impact.
Our world-class R&D team has been building the know-how and technology platform to produce meat, fish and dairy foods from plants. Impossible Foods is experiencing rapid growth and is resolutely committed to leading all aspects of the plant-based food revolution—from discovery to commercial production. The only thing that will separate Impossible Foods from success and failure is our ability to recruit more world-class experts.
Want to join? Check out the job opening and requirements below:
Bio-manufacturing Quality Engineer is primarily responsible for ensuring product quality using industry best practices in the areas of Design, Production, and Process Control throughout the production cycle. The Quality Engineer will be also responsible for providing quality engineering support for manufacturing. This individual will work with engineering teams, R&D, Ops team and quality teams within the company. This position requires knowledge of the regulatory environment (FDA, GMP and related OSI regulations ). Candidates should also have knowledge and experience to support Design for Reliability and Manufacturability (DRM), Design for Six Sigma, Design for Lean Six Sigma.

You Will:

  • Participate in solicitation, definition, and review of customer specifications, product requirements, design specifications, verification, and validation testing and risk assessment activities.
  • Tagging and tracing of requirements to specifications and testing.
  • Review of the following components of the Quality System: PQP, C&Q, FSHA.
  • Contribute to development and review of process validations (IQ, OQ, PQ).
  • Apply statistical techniques to receiving inspection, manufacturing, and validation processes.
  • Develop quality inspection criteria for incoming inspection and in-process inspection.
  • Ensure procedure adherence for controlled environment room.
  • Interface with Operations to assure that quality considerations and requirements are adequately covered in manufacturing procedures, equipment selection, design, validation, and training.
  • Conduct internal audits and supplier audits to assure compliance and effectiveness of the Quality System.
  • Participate in root-cause analysis and corrective and preventive actions.
  • Support Quality Objectives, including analysis and regular trending of key quality system elements.
  • Generate or update standard operating procedures to define and improve quality system functions.
  • Train cross-functional groups on the usage of an electronic document management system.
  • Track and update periodic QA / Document Control metrics and dashboards.
  • Participate in the implementation and monitoring of the training program.
  • Participate in and support quality audits (internal and external), troubleshooting efforts, and other Quality System processes.
  • Communicate with Suppliers to obtain pertinent information required per project.
  • Perform supplier assessments in accordance with the company’s and CMO’s SOPs.
  • Control and organization of paper records, both active on-site and off-site archives.
  • Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.

You Have:

  • Bachelor’s Degree in a science related field (Microbiology, Biology, Chemical Engineering etc. ) or other technical discipline.
  • At least 5 years of quality engineer experience in the food/pharma/bio manufacturing field. 
  • Ideally certified ASQ Quality Engineer.
  • Proven ability to establish, optimize and maintain world-class quality system and team.
  • Ideally LSSGB or LSSBB certified or experience using structured and data driven problem-solving techniques (DMAIC, LEAN, TPM, Zero Loss work culture, etc.).
  • Excellent communication, leadership and interpersonal skills.
  • The ability to influence others and be a team player.
  • The ability to develop/implement core work practices and standards that ensure excellence in quality.
  • The ability to rapidly assess, analyze, and quickly resolve complicated quality problems with little initial information or direction and with varying degrees of ambiguity.
  • The ability to multitask and manage priorities while allocating time to long-term, quality continuous improvement projects.
  • Strong “self-management” skills and be comfortable working with minimal supervision.
  • Established project management skills. Must bring leadership, interpersonal and communication skills required to interact with various levels of plant and corporate personnel and influence others.
  • Willingness to work flexible schedules as needed to support 7-day per week, 24-hour per day production facilities. Work schedules could include occasional off-shift or weekend work.
Impossible Foods Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. 
Depending on your location, the California Consumer Privacy Act (CCPA) may regulate the way we manage the data of job applicants. Our full notice outlining how data will be processed as part of the application procedure for applicable locations is available here: https://impossiblefoods.com/careers/notice. By submitting your application, you are agreeing to our use and processing of your data as required.

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