Lab Technologist – Clinical Laboratory & IVD Validation
Location : On-site
Type : Contract (1 year with extensions)
Shift : Standard business hours (M–F)
Pay Range : $36–$40 / hour (depending on experience)
A leading innovator in the in-vitro diagnostics (IVD) space is seeking a Lab Technologist to support the development and validation of cutting-edge diagnostic devices. This role is ideal for professionals with deep clinical lab experience and a passion for driving innovation in healthcare technology.
Key Responsibilities
- Support the design, testing, and reporting of new or updated IVD devices.
- Operate and maintain a variety of lab instruments and platforms.
- Lead and manage clinical studies and complaint investigations.
- Collaborate with R&D to develop and implement new testing methods.
- Conduct Clinical Software Validations (CSV) and instrument qualification (IQ / OQ / PQ).
- Apply quality and regulatory standards (GLP, GCP, ISO) to lab processes.
- Troubleshoot technical issues using scientific judgment.
- Work cross-functionally with teams in manufacturing, marketing, quality, and regulatory.
Must-Have Qualifications :
5+ years of experience in a clinical laboratory environment.Hands-on experience with manual differential testing .Urinalysis testing experienceProven track record in instrument validation / qualification (IQ / OQ / PQ).Bachelor’s or Master’s degree in Clinical Laboratory Science, Medical Technology, Biology, Life Sciences, or a related health field.Preferred Skills & Technologies :
Familiarity with IVD platforms and lab automation systems.Knowledge of regulatory frameworks : GLP (Good Laboratory Practice), GCP (Good Clinical Practice), ISO standards .Experience with CSV (Clinical Software Validation).Strong documentation and reporting skills.