Validation Engineer 3
Helix
San Diego, CA
Validation Engineer 3
Position Type:
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