Lab Systems Engineer - Compliance & Validation

Caris Life Sciences; Phoenix (AZ); On-site; USD 90,000 - 130,000; Full time

Job summary

Caris Life Sciences is seeking a regulatory/compliance professional to ensure equipment records meet GDP, CLIA, CAP, ISO 13485, and FDA standards within the asset lifecycle. You will author and review instrument reports, support requalification, and ensure data integrity across laboratory instrumentation records.

Collaborating with Systems, IT, and Quality teams, you will participate in audits, implement SOPs, and manage documentation to maintain regulatory compliance and operational efficiency.

Qualifications

• Bachelor's degree in engineering, biological sciences, computer science, or similar field.
• Strong knowledge of QMS requirements per CAP/CLIA, ISO 13485, and 21 CFR Part 820.
• One year of experience working in a regulated laboratory environment.
• Proficient in Microsoft Office Suite (Word, Excel, Outlook) and general internet usage for business.

Responsibilities

• Ensure equipment verification record compliance with all applicable regulatory requirements (CLIA, NYS, CAP, ISO, FDA, IVDR, etc.).
• Collaborate and assist in clinical requalification of instrumentation to maintain company-wide regulatory compliance and operational efficiency.
• Author cross-correlation reports for Molecular, IHC and liquid profiling workflows.
• Ensure requalification paperwork is reviewed and approved in a timely fashion.
• Review records for accuracy and Good Documentation Practices (GDP).
• Analyze system/process dependencies between laboratory instrumentation, operations, IT infrastructure, and Quality to define and execute projects within the validation programs.
• Participate in internal and external audits with tasks such as audit preparation, answering questions, and providing documentation to auditors.
• Support asset lifecycle management activities.
• Author, review, revise, and implement standard operating procedures (SOPs).
• Manage company records in accordance with regulatory requirements and company policies.
• Engage in cross-functional collaborations between Systems Engineering, Laboratory, IT, Software QA, and Quality teams to support program alignment between organizational and regulatory requirements.

Skills

QMS knowledge

Regulatory compliance

Documentation

Education

Bachelor's degree in engineering/biological sciences

Master's degree preferred

Tools

Excel

Word

Outlook

Job description

Caris Life Sciences is seeking a regulatory/compliance professional to ensure equipment records meet GDP, CLIA, CAP, ISO 13485, and FDA standards within the asset lifecycle. You will author and review instrument reports, support requalification, and ensure data integrity across laboratory instrumentation records.

Collaborating with Systems, IT, and Quality teams, you will participate in audits, implement SOPs, and manage documentation to maintain regulatory compliance and operational efficiency.