Informatics platform to accelerate, measure, and forecast R&D from discovery through bioprocessing
Systems Validation Engineer
Over the next 10 years, biotech will fundamentally rewrite the way we live. Gene editing and cell therapy will dramatically change how we treat cancer and other major illnesses. Biofuels and biomaterials will transform the cars we drive, the clothes we wear, and the makeup of everyday objects. Crop science and synthetic biology will produce sustainable and ethical food. Benchling’s mission is to accelerate the research that propels us towards this future, and magnify its impact, through modern software.
Every day, scientists around the world use Benchling in their efforts to solve humanity's most pressing problems. For these scientists, Benchling is the central technology they use to conduct their research.
Benchling was founded by a team of MIT graduates and has raised funding from Benchmark, Andreessen Horowitz, Thrive Capital, and Y Combinator. Our customers include pharmaceutical giants, leading biotechs, and the world's most renowned research institutes.
As a* Systems Validation Engineer *at Benchling you will lead the formal Verification and Validation procedures at Benchling to help deliver a validated product offering for our GxP compliant customers. You will be an integral part of our Quality team and partner with Product Managers, product & quality focused Software Engineers.
- Review software requirements, technical designs, and verification test plans
- Ensure traceability of requirements to Validation plans, technical designs, verification plans, test cases and test results
- Create & review Validation plans, IQ/OQ/PQ protocols, User Acceptance Tests, and Validation Summary Reports
- Create risk analysis reports for change requests, code changes, software defects and releases
- Create Pareto failure reporting, metrics and monitoring across releases for key product components
- Support internal and external audits as needed
- 2-5 years experience with Validation of enterprise R&D, Lab or Manufacturing Systems used in Life Sciences
- 2-5 years experience creating Validation Plans, Protocols (IQ/OQ/PQ), Trace Matrices, and Validation Summary Reports
- Understanding of 21 CFR Part 11, GAMP 5, GLP and/or GMP regulations and principles of computer systems validation
- Knowledge of Agile software development and software testing methodologies a plus
- B.S. in life sciences or biological sciences
- Empower through information. We explain the “why” behind every decision, unless there are highly sensitive circumstances. We're honest about how we're doing, especially in difficult times. We believe that sharing information builds trust and enables better decision-making.
- Rely on tenacity. Hard work is one of the greatest factors to determine success and is fully under our control. We must make the most of every day by bringing the highest level of determination. Dreaming big is not enough.
- Raise the bar. Pushing ourselves and others to improve will be uncomfortable and at times result in failure. However, it's critical to our success. We're dedicated to creating a place where everyone feels challenged to improve.
- Build a lever. We choose to build tools and infrastructure that will help others make world-changing innovations. There's less glory in it, but in the words of Archimedes, "Give me a lever long enough and a fulcrum on which to place it, and I shall move the world."
PERKS AND BENEFITS
- Beautiful, light-filled office in the Financial District of SF
- Monthly health & wellness stipend
- Work with a talented yet humble team
- Meals and snacks covered
- Medical, dental, and vision insurance
- Commuter benefits
- Happy hours, company and team wide social events
We are an equal opportunity employer and 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.