Validation Engineer
UPSIDE Foods
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See open jobs at UPSIDE Foods.See open jobs similar to "Validation Engineer" Threshold.Glenview, IL, USA
Posted on Saturday, August 12, 2023
About us
Based in Berkeley, CA, UPSIDE Foods grows meat, poultry, and seafood directly from animal cells. These products are not vegan or vegetarian—they are delicious meat, made without the need to raise and slaughter billions of animals. In a historic first, UPSIDE Foods received regulatory approval to sell its product in the US in June 2023.
Founded as the world’s first cultivated meat company in 2015, UPSIDE Foods (formerly Memphis Meats) has achieved numerous industry-defining milestones, including being the first company to produce multiple species of meat (beef, chicken, and duck). The company believes that people shouldn’t have to choose between the foods they love and a thriving planet, and is working to build a better food system with access to delicious, humane, and sustainable meat, poultry, and seafood. UPSIDE Foods has won various industry awards, including New York Times’ Good Tech Awards, FastCo’s Next Big Thing in Tech, and the Best and Brightest Companies to Work For in the Nation by the National Association for Business Resources. UPSIDE Foods has raised a total of $608 million, including from the Abu Dhabi Growth Fund (ADG), Baillie Gifford, Bill Gates, Cargill, John Doerr, John Mackey, Kimbal and Christiana Musk, Norwest, Richard Branson, Softbank, Temasek, Threshold, Tyson Foods, and others.
About this job
UPSIDE has grown fast over the last two years, and the momentum continues with the design for our first GMP commercial production facility! The Validation Engineer will lead the development of our commissioning and validation strategies. We’re looking for someone who enjoys fast-paced growth, is comfortable with change, and is passionate about working with a growing team in a developing industry. Your primary responsibility will be to develop and implement the commissioning and validation strategies along with the execution plans with the working team. With immediate growth in both the commercial facility and the company overall, the right person will be energized in contributing to a team that’s going to change the future of food!
Responsibilities include
- Draft commissioning and qualification strategies for the commercial facility, including the Validation Master Plan.
- Support development of detailed Commissioning and Qualification schedule and subsequent tracking of activities to ensure adherence.
- Support development of commissioning and qualification Standard Operating Procedures as required to support the project scope initially, as well as the ongoing maintenance of qualified status long-term.
- Facilitate and support vendor activities that may be leveraged for commissioning and qualification (FAT, SAT).
- Draft qualification documentation for equipment including System Impact Assessments (SIA), System Risk Assessments, User Requirement Specifications (URS), Design Qualification, Installation, Operational and Performance Qualification Documentation.
- Provide support for and/or execute DQ/IQ/OQ/PQ Protocols.
- Write reports summarizing execution of protocols.
- Work with cross functional teams, system owners, contractors, and stakeholders to enable efficient design and execution of strategies and validation activities.
- Opportunity to grow and lead the internal validation engineering staff as internal growth is needed to support the project.
- Responsible for oversight of validation contractors.
About you
- Bachelor's degree in engineering, with a minimum of 6+ years of validation engineering experience; preferred in biopharma, GMP food production, or similar industry operating in a regulated environment.
- Excellent understanding of large-scale manufacturing processes for food, biopharmaceuticals or equivalent.
- Extensive knowledge of engineering validation principles and approaches for GMP facilities.
- Strong skills in team work, attention to detail while understanding the big picture.
- Use proven people and task management skills to keep scope of work on schedule and on-budget.
- Strong communication skills, especially in written form to satisfy regulatory expectations.
- Enjoy fast-paced and complex environments, mentoring team members (including contractors), and always striving to make processes and experiences better.
Who you’ll work with
- While we expect growth in all functions in the next 1-2 years as part of the commercial facility design and startup activities, this role will most frequently interact with technical subject matter experts in process/engineering/facilities, engineering and validation contractors, and Quality Assurance and Quality Testing personnel.
Key Contributions in First Year
- Review and understand the validation strategy and history of UPSIDE’s GMP plant facility in Emeryville, CA.
- Develop the Commissioning and Validation Strategies for the Commercial Manufacturing Facility, including the Validation Master Plan.
- Develop specific validation protocols and plans for facility equipment (process & utilities) and systems.
- Plan for and coordinate the plan of attack for commercial facility validation as equipment and systems come on line in a rolling fashion, including working with contract validation firms.
- Support schedule and cost development for the Commissioning and Qualification.
UPSIDE Benefits!
- Stock options for all full-time incoming team members!
- 90-100% employer-paid healthcare premiums for team members (medical [including HSA and FSA], dental, and vision)
- Pet insurance for your furry family members!
- Unlimited PTO
- DE&I (Diversity, Equity & Inclusion) Council and People Engagement Programs
- Company-sponsored learning & development opportunities
UPSIDE Foods is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Our company-wide mission is to create a product for everyone, so we are deeply committed to having teams and leaders that reflect this mission.
This job is no longer accepting applications
See open jobs at UPSIDE Foods.See open jobs similar to "Validation Engineer" Threshold.
