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Lead Verification Engineer (job code: 89861)

Employer
DNA Script
Location
Daly City
Start date
Jun 3, 2024

View more

Discipline
Engineering, Chemical Engineer, Science/R&D, Biology
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details

DNA Script

DNA Script is a leading company in the production of nucleic acids for genomic, synthetic biology and biopharmaceutical applications.

Our clean, efficient Enzymatic DNA Synthesis (EDS) technology, implemented on a benchtop instrument (the SYNTAX), accelerates innovation in life science and biotechnology through the decentralization of rapid, on demand and high quality DNA synthesis.

Our approach builds upon nature's billions of years of evolution in enzymatically synthesizing DNA, setting new standards for assembling nucleic acids to accelerate scientific discovery and DNA/RNA production in disciplines with profound impacts upon humanity.

DNA Script has a broad stable of high quality investors and is capitalized to continue its progress to full commercialization of the technology and products. We are building an organization across our two sites, in Paris and San Francisco, with the talent, skills and attitude to achieve our mission: to unlock the power of “DNA-write”.

This is an opportunity for a dynamic individual to join an international and highly skilled team, and to make significant contributions to commercializing a technology with far-reaching potential across the biological sciences and beyond.

Main Responsibilities

  • Lead the definition, design, and execution of system verification activities on instrument projects.
  • Provide guidance and prioritization of verification related tasks in alignment with company business objectives.
  • Contribute to the development and growth of junior team members.
  • Provide mentorship and support through technical guidance/training.
  • Determine strategy for testing product and sub-system requirements, including how requirements will be tested, sample size, resource and material needs.
  • Coordinate testing via knowledge of both Mechanical and Electrical disciplines on the Hardware-side with Biological and Chemical disciplines on the Performance-side.
  • Develop, write, and execute system verification test methods to evaluate product requirements and augment user-oriented testing.
  • Develop high quality and statistically powered experiments and test methods based on Design of Experiments Techniques and related approaches.
  • Utilize change control documentation practices in each phase of verification.
  • Document planned and unplanned deviations, ensure that such changes are appropriately reviewed and analyzed.
  • Generate comprehensive test reports, recommendations for corrective action, and project risk assessment based on verification results.
  • Hold stakeholder design reviews to present verification results to a cross-functional audience.
  • Use manufacturing, test, development, and/or diagnostic equipment, including, but not limited to, test programs, oscilloscopes, signal generators and specialized test apparatus.
  • Improve system robustness & stability through experimental observations.
  • Conduct root cause analysis investigations and facilitate escalations to cross-functional development teams to drive resolution. Inclusive of mechanical, electrical, software, firmware, reagent, and consumable elements.
  • Maintain a clean work environment including instruments and equipment and workspace.

 

Qualifications and Education Requirements

  • Master or foreign equivalent in Chemical Engineering, Biological Engineering or related field.
  • 2 years experience as Validation Engineer or related occupation.
  • Will also accept Bachelor’s degree or foreign equivalent in Chemical Engineering, Biological
  • Engineering or related field plus 5 years progressive experience as Validation Engineer or related occupation.

Other Skills and Abilities

  • Must have at least 1 year of prior work experience in each of the following:

    1. Verification and validation experience in one of the following regulated industries: in vitro diagnostics, medical device, or biotech

    2. Systems verification and validation principles while working in biotech, pharma industry, or clinical research

    3. Develop, author and review system specifications, risk assessments, plan, protocols, and reports as they relate to the system and intended use to evaluate product requirements

    4. Development and execution of test method validations, installation and qualification of systems, and Computer Systems Validation

    5. Identifying and remediating issues found during testing

 

Miscellaneous

  • Job located in Daly City, California
  • Salary: $155,958 - $155,958

Company

DNA Script is a leading company in manufacturing de novo synthetic nucleic acids using enzymatic DNA synthesis (EDS) technology. The company aims at accelerating innovation in life science and technology through the decentralization of rapid, on demand and high-quality DNA synthesis. DNA Script's approach leverages nature's billions of years of evolution in synthesizing DNA to set a new standard for customizing nucleic acid synthesis thus accelerating discovery in genetics, genomics, and synthetic biology. Discovery disciplines with profound impacts upon humanity such as biopharma, translational genetics and even molecular information storage all start with synthetic DNA. The company has recently initiated the commercialization of its first EDS powered platform, the SYNTAX system. 

To date, DNA Script has raised over $315M of financing, with leading investors such as Coatue Management, Fidelity Management and Research, Catalio Capital Management, Casdin Capital, LSP, Bpifrance Large Ventures, Danaher, Illumina Ventures, Agilent, Merck Ventures, Sofinnova Partners, Kurma Partners, T Rowe Price, Baillie Gifford and Eurazeo. 

DNA Script also partners on technology and product development with leading organizations such as DARPA, IARPA, Moderna Therapeutics, GE Research, Illumina, the Broad Institute, Harvard University, Institut Pasteur and the French Department of Defense.

DNA Script has its research and manufacturing facilities headquartered in Paris, France, and is in the process of expanding its commercial and development teams in South San Francisco.

Opportunity and Challenges 

We are looking to assemble a team of best-in-class, innovative and passionately eager people.  We want to gather their talents and skills to achieve one goal: unlock the power of “DNA-write.” We offer the opportunity of joining a dynamic, international, and highly skilled team in a pioneering startup. Our DNA On Demand platform not only has the potential to change the way the world makes and uses synthetic DNA, but also to accelerate the rate of discovery by delivering upon the promise of same-day results.

This is an opportunity to join a rapidly growing company and to have a large impact on developing a technology that will have far-reaching impacts across biological sciences.
 

French office: 67 avenue de Fontainebleau, 94 270 Le Kremlin-Bicêtre

US Headquarters: 2001 Junipero Serra Blvd. Suite 400, Daly City, CA 94014, USA

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Company info
Website
Phone
650-457-0844
Location
2001 Junipero Serra Blvd. Suite 400
Daly City
CA
94014
United States

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