Engineer II, Validation
Core
Execute validation activities for clinical diagnostic reagent manufacturing in a cGMP, FDA, and ISO 13485 regulated environment.
Role type
Validation Engineer
Builds
Validated equipment, systems, and processes for clinical diagnostic reagents
Domain
Life Sciences / Clinical Diagnostics / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation protocol authoring (IQ/OQ/PQ), Risk-based quality tools (FMEA, RCA, CAPA), cGMP/FDA/ISO 13485 compliance, Statistical process control, Calibration and metrology principles, Change control management, Deviation investigation, Cross-functional collaboration
Preferred skills
Experience with automation systems and computer system validation, Project management
Technologies
Microsoft Office
Responsibilities
Support creation and execution of validation master plans, Author and execute validation protocols and reports, Participate in periodic validation reviews and gap assessments, Analyze validation data to verify acceptance criteria, Support deviation investigations and root cause analysis, Collaborate with Engineering, Quality, and Manufacturing departments
Seniority
Mid-level IC
