Sr. Associate Validation Engineer
Core
Ensuring pharmaceutical storage, distribution, and transportation systems remain validated and compliant with GMP/GDP regulations through qualification, validation, and calibration activities.
Role type
Associate Validation Engineer (Pharmaceutical Logistics)
Builds
Validated facilities, equipment, utilities, and transportation systems for pharmaceutical storage and distribution
Domain
Healthcare / Pharmaceutical Logistics / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation lifecycle management, protocol authoring, data analysis, technical reporting, change control, deviation investigation, CAPA support, calibration management, regulatory compliance (GMP/GMP), risk assessment
Preferred skills
Temperature mapping, thermal validation, Kaye Validators, data loggers, environmental monitoring systems, calibration management systems, MasterControl
Technologies
Microsoft Office, MasterControl, Kaye Validators
Responsibilities
Author and execute qualification and validation protocols (DQ, IQ, OQ, PQ), coordinate qualification activities for facilities and equipment, conduct data collection and analysis for validation studies, support Management of Change and investigations, review calibration records, assist with audit preparations, participate in process improvement initiatives
Seniority
Mid-level, hands-on IC
