Helix is hiring a

Senior Validation Engineer

San Carlos, United States

We believe that everyone benefits from their biological information. It’s our mission to empower every person to improve their life through DNA. With our high-quality, trusted partners and state-of-the-art lab, we’ve created the first platform of personalized products and services powered by genetics. From inherited cancer screening to custom fitness and nutrition plans, the world of DNA learning is becoming more accessible and more valuable than ever.

So far we’ve raised over $100 million from investors like Illumina (the world’s leader in genetic sequencing equipment), Warburg Pincus, Sutter Hill Ventures, and Kleiner Perkins. We’ll be working with partners such as National Geographic, the Mayo Clinic, Invitae, and many others to develop applications which interpret your genome, with an app store and marketplace launching in 2017.

Our big vision comes with big responsibility. That’s why we’re building a team of experts in the field of genetics, engineering, design, business development, and beyond to help bring actionable insights to our customers. We’re looking for the best and brightest minds who are passionate about our mission and are excited to work on a truly diverse team.

Helix is headquartered in San Carlos, with our genetic sequencing lab located in San Diego.

As a Senior Validation Engineer, you would have an integral role in implementing software medical device lifecycle processes, and work closely with the Bioinformatics team to support regulatory submissions and compliance activities. This position provides an unique opportunity to make an immediate impact, and lay the foundation for processes and procedures in a fast-paced dynamic environment. If you are looking for the opportunity to lead and make a significant contribution, this role provides an empowering and action-oriented environment to take your career and our mission to the next level.

If you are interested in applying your software compliance skills and knowledge to a company that is poised to bring cutting-edge technology and novel products to the market, join our team. 

As Senior Validation Engineer, you will:

  • Establish computerized system validation program in accordance to 21 CFR Part 11 and 21 CFR 820, and 21 CFR 820.70.  
  • Develop and execute Validation Plans, validation deliverables (IQ, OQ, PQ), requirement traceability matrix, URS/FRS, and summary reports for computerized systems.
  • Develop validation master plans/project plans (VMP), revalidation plans and standard operating procedures (SOP) as necessary.
  • Coordinate validation activities with Engineering and Laboratory support groups for timely protocol executions.
  • Provide direction on CAPA activities including scope and implementation plans.  
  • Support internal and external audits and inspections
  • Other duties as assigned

Required background:

  • Bachelor’s Degree in Engineering, Life Science.  
  • 6-8 years in Quality Validation experience in validation of computerized systems (LIMS, ERP, Quality Management Systems).
  • Skilled to lead, mentor and train teams on relevant processes
  • Attention to detail, strong organization skills, and ability to work independently and in teams
  • Ability to operate flexibly in fast-paced environment
  • Able to deliver quality outputs under minimal supervision

What Helix has to offer you

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
  • 401(k) with employer matching
  • Catered meals
  • Unlimited vacation
  • Commuter benefits
  • Gym subsidy

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