Validation Engineer 3

Company Name:

Helix

Job Location:

San Diego, CA

Position Title:

Validation Engineer 3

Position Type:

Full-time

General Job Description:

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.

Responsibilities:

  • 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)

Qualifications:

  • 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.

Application Information & Contact (How to Apply)

Please apply on our website career page