Validation Engineer 3
We believe that everyone benefits from their biological information. It is 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 have 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 have raised over $300 million from investors like Illumina (the world’s leader in genetic sequencing equipment), Warburg Pincus, Sutter Hill Ventures, Kleiner Perkins Caufield & Byers and Draper Fisher Jurvetson Growth. Our app store and marketplace include partners such as National Geographic, Admera Health, Vinome and many others, with whom we have partnered to develop applications which interpret your genome.
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 with a truly diverse team.
The individual will have an opportunity to work at the state of art facility and advanced sequencing technology. This position will allow us to qualify analytical laboratory instrument and in-house developed software. This position will report to Sr Validation Manager.
The Helix Quality and Regulatory team is 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.
As Validation Engineer III you will:
- 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)
- Bachelor in Biomedical Engineering or similar focus, plus 7 years of experience or Master’s in Biomedical Engineering or similar focus, plus 5 years of experience
- 5 -7 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.
The ideal candidate will 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
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
- 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
Helix is proud to be an equal opportunity employer, and committed to providing employment opportunities regardless of race, religious creed, color, national origin, ancestry, physical disability, mental disability, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, pregnancy, childbirth and breastfeeding, age, sexual orientation, military or veteran status, or any other protected classification, in accordance with applicable federal, state, and local laws.