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Company

Original Job Post

DNA Script · 2 days ago

Lead Verification Engineer

Daly City, CA

Full-time

Onsite

Senior Level

$156K/yr - $156K/yr

2+ years exp

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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.

Qualification

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Validation EngineerValidationRegulated Industries ExperienceSystems VerificationBiotech IndustryPharma IndustryClinical ResearchSystem SpecificationsRisk AssessmentsTest Method ValidationsComputer Systems ValidationIssue Remediation

Required

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.

Preferred

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

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

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

- 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

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

- Identifying and remediating issues found during testing

Company

DNA Script

DNA Script is a disruptive DNA synthesis company harnessing biology to accelerate breakthroughs in life science and human health.

Founded in 2014

Le Kremlin-bicêtre, Ile-de-France, FRA

201-500 employees

https://www.dnascript.com

H1B Sponsorship

DNA Script has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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Trends of Total Sponsorships

2023 (3)

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