Senior Scientist Electronic Laboratory Systems
Core
Perform technical support and validation exercises for electronic laboratory systems and analytical equipment in a GMP-regulated QC environment.
Role type
Senior Scientist Electronic Laboratory Systems
Builds
Qualified and validated QC laboratory systems and applications
Domain
Life Sciences / Pharmaceutical Quality Control
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
GMP regulations knowledge, Computerized System Validation (CSV), LIMS (SM LIMS, Chromeleon, Lab X, Empower), analytical data evaluation, deviation investigation, regulatory standards (ISO, FDA, USP, EP), electronic laboratory systems operation
Preferred skills
IT/Automation background, programming or database experience, practical process improvement
Technologies
SM LIMS, Chromeleon, Lab X, Empower
Responsibilities
Operate, maintain, and troubleshoot analytical laboratory equipment and electronic laboratory systems; Support qualification of analytical equipment and computerized system validation activities; Generate, review, and maintain GxP documentation; Evaluate analytical data and document results; Support investigations related to out-of-specification, out-of-expectation, deviations, change controls, and corrective and preventive actions; Provide timely technical support to QC laboratory units; Support inspection and audit readiness activities; Contribute to the implementation of automated data flows and laboratory process improvements
Seniority
Senior, hands-on IC
