Validation Engineer
Core
Provides technical support for equipment/system initial validation, requalification, and compliance with cGMPs in a pharmaceutical manufacturing environment.
Role type
Validation Engineer
Builds
Validated pharmaceutical manufacturing systems and equipment
Domain
Pharmaceutical manufacturing / cGMP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP knowledge, equipment commissioning, protocol preparation, data analysis, statistical analysis, report writing, deviation investigation, root cause analysis
Preferred skills
Certified to enter Controlled Areas (Grade D, C, B, A), experience with analytical instruments (dataloggers, lyophilizers, sterilizers)
Technologies
temperature/humidity dataloggers, lyophilizers, warehouses, sterilizers, incubators
Responsibilities
Schedule and execute equipment commissioning, qualification, and requalification; execute validation studies including protocol preparation and execution; program and operate analytical instruments; participate in validation program improvements; conduct deviation investigations to define corrective and preventative actions
Seniority
Individual Contributor
