Biotechnology is rewriting life as we know it, from the medicines we take, to the crops we grow, the materials we wear, and the household goods that we rely on every day. But moving at the new speed of science requires better technology.
Benchling’s mission is to unlock the power of biotechnology. The world’s most innovative biotech companies use Benchling’s R&D Cloud to power the development of breakthrough products and accelerate time to milestone and market.
Come help us bring modern software to modern science.
ROLE OVERVIEW
Over the coming years, biotech will fundamentally rewrite the way we live. Gene editing and cell therapy are dramatically changing how we treat cancer and other major illnesses. Biofuels and biomaterials are transforming the cars we drive, the clothes we wear, and the makeup of everyday objects. Crop science and synthetic biology are producing sustainable and ethical food. Benchling’s mission is to accelerate the research that propels us towards this reality, and magnify its impact, through modern software.
Every day, scientists around the world use Benchling’s applications, platform, & analytics in their efforts to solve humanity's most pressing problems. For these scientists, Benchling is the central technology they use to conduct their research. Our customers include pharmaceutical giants, leading biotechs, and the world's most renowned research institutes.
As a Systems Validation Engineer at Benchling you will be responsible for supporting the validation activities for Benchling’s GxP offering. You will collaborate closely with Product Managers, Customer Success and Engineering teams in creating the best-in class validation packages for our customers.
YOUR IMPACT
- Execute the validation activities for assigned projects/applications supporting Benchling’s General Releases, Patches, Product re-baselines
- Author and implement internal GxP impacting business systems (such as EDMS, CAPA, LMS)
- Responsible for tracking, monitoring and controlling validation process to ensure timely delivery to meet pre-scheduled release dates
- Review software requirements, technical designs, and verification test plans
- Author and execute Validation deliverables such as Validation Plan, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports using a risk-based approach
- Initiate and manage test deviation to closure and maintain deviations log
- Ensure traceability of requirements to Validation plans, technical designs, verification plans, test cases and test results
- Support change control as validation technical resource and ensures timely completion of required tasks
- Compile and maintain Validation documentation for assigned projects
ABOUT YOU
- 5-7 years experience with validation of enterprise R&D, lab or manufacturing systems/software used in Life Sciences
- 5-7 years experience creating Validation Plans, Protocols (IQ/OQ/PQ), Validation Assessments, Trace Matrices, and Validation Summary Reports
- Understanding of 21 CFR Part 11, Annex 11, GAMP, GLP, GCLP and/or GMP regulations and principles of computer systems validation
- Knowledge of Agile software development and software testing methodologies a plus
- B.S. in engineering, life sciences or biological sciences
#LI-GP1
We are an equal opportunity employer. That means we don’t discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We also consider for employment qualified applicants with arrest and conviction records, consistent with applicable federal, state and local law, including but not limited to the San Francisco Fair Chance Ordinance.
Our leadership principles guide how all Benchlings can lead by example:
- Admit mistakes and shortcomings
- Deliver results
- Disagree and commit
- Obsess over customers
- Rely on work ethic
- Show empathy
- Recruit and develop the best
- Sweat the details
- Think and communicate clearly
- Unite around the mission
For applicants for U.S.-based roles only: All new hires in the United States are required to be fully vaccinated against COVID-19 and to provide proof of vaccination prior to their first day of employment. If you are unable to be vaccinated for medical or religious reasons, we will explore potential reasonable accommodations; however, Benchling may not be able to grant such accommodations in all cases if doing so would cause undue hardship.
If you are a Colorado resident: Please contact us by emailing [email protected] to receive compensation and benefits information for this role. Please include the job title in the subject line of the email.
