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Lead Verification Engineer (job code: 89861)

Résumé du poste
CDI
Le Kremlin-Bicêtre
Salaire : Non spécifié
Télétravail non autorisé
Éducation : Bac +3
Compétences & expertises
Contenu généré
Outils et d'équipements de nettoyage
Mentorat

DNA Script
DNA Script

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Le poste

Descriptif du poste

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

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