Validation Engineer III

Organization
Helix
Job Location
9875 Towne Center Drive
San Diego, CA 92121
Benefits

Aside from working alongside brilliant, dedicated, passionate, down-to-earth, curious, warm, and thoughtful people, we also provide great benefits:

  • Competitive compensation, including meaningful equity
  • Health insurance, including medical, dental, and vision
  • 12 weeks of Maternity or Paternity leave
  • 4 weeks of paid Pregnancy Disability
  • 401(k) with employer matching
  • On-premise nursing room
  • Corporate fitness rate
  • Commuter benefits
  • Catered meals
  • Flexible PTO
Job Description

The Helix Quality and Regulatory team are seeking passionate and motivated individuals to join our cross-functional team to oversee validation activities for our San Diego lab. You will work closely with lab operations and QA to validate lab instruments and software and advise cross-functional teams. If you like the idea of working independently in a hands-on environment while learning new technology and working at a state of the art semi-automated laboratory, then this is the ideal opportunity for you!

Continue to advance your career as you:

  • Conduct validation and interphase for analytical laboratory instruments, Clarity LIMS, and customized application/software
  • Maintain expertise in CSV, GAMP 5, 21 CFR Part 11, 21 CFR 820.70 to assess lab instrument and computerized system requirements and utilize a risk-based approach to validate the systems
  • Author and update validation deliverables including, but not limited to: assessments, URS, FDS, DS, IQ, OQ, PQ, RTM, VSR
  • Provide validation representation on cross-departmental team projects, including escalation of outstanding issues
  • Study and recommend techniques to improve existing processes
  • Execute protocol, author discrepancy and follow the quality system to arrive at a resolution
  • Perform audit trail review, follow up on corrective actions
  • Maintain a high ethical standard and enforce data integrity through the validation process
  • Ensure that the testing is sufficient to meet regulatory requirements (21 CFR Part 11, 820.70, ISO 13485, ISO 14971, and IEC 62304)
Requirements

We will be looking for you to have:

  • Bachelor in Biomedical Engineering or similar focus, plus 5 years of experience or Master’s in Biomedical Engineering or similar focus, plus 3 years of experience
  • 3-5 years of experience validating lab instruments, customized computerized systems, and the systems interphase
  • Prior experience defending validation work during regulatory body audits
  • Demonstrated ability to work well in a cross-functional team environment
  • Strong written and oral communication skills
  • Prior experience validating systems per GAMP 5 methodology
  • Prefer to have prior experience with testing approach including, but not limited to: unit, integration, user acceptance testing, regression testing, and smoke testing, is preferred.

It would be even better if you have:

  • Prior validation experience with sequencing instruments, pipetting instruments, laboratory equipment (e.g., freezers, walk-in freezer) and custom applications (e.g., LIMS, BaseSpace)
  • Prior validation experience in a medical device company with the following regulations: ISO 13485, ISO 14971, and IEC 62304
About Our Organization

Founded in 2015, Helix launched the first-ever marketplace for DNA discovery. Our advanced technology and state-of-the-art lab deliver 100x more data than other at-home DNA tests. We integrate that data in DNA-powered health, ancestry, and wellness products from an ever-growing list of name-brand and developer partners on our platform, including the Mayo Clinic, National Geographic, and LoseIt!

Our mission is to empower every person to improve their life through DNA. Accomplishing this is no small feat; it takes a community of pioneers to make a difference in the lives of millions. Our people are our power, and we have a dedicated team of experts in the fields of genetics, engineering, design, product and beyond who have united to champion better lives for all. We are here to accomplish something bigger than ourselves. Join us and make your difference.  

We're headquartered in San Carlos, with additional offices in San Diego, San Francisco, and Denver. We've raised over $300 million from investors like Illumina (the world leader in genetic sequencing equipment), Warburg Pincus, Sutter Hill Ventures, Kleiner Perkins Caufield & Byers, and Draper Fisher Jurvetson Growth. Learn more about life at Helix.

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