Engineer, Validation Commissioning
Core
Design and execute robust evaluation, testing, and documentation strategies for commissioning, qualification, and validation of automated systems, equipment, facilities, and processes to support risk management and regulatory compliance.
Role type
Validation Commissioning Engineer
Builds
Commissioning, qualification, and validation test protocols; User Requirements Specifications; Functional/Design Specifications
Domain
Pharmaceutical/Medical Device Manufacturing (Healthcare, Nutritional Products, Laboratory Diagnostics)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computer System Validation (CSV), Risk Management (FMEA), Validation Master Plan execution, Specification development, Test protocol execution, Troubleshooting (control logic, instrumentation, recipes)
Preferred skills
Automation systems (PLC/SCADA), Process controls, Quality/Compliance regulations (API, Bulk Drug, Finished goods), Multi-project management
Technologies
PLC, SCADA, FMEA, Validation Master Plan
Responsibilities
Develop User Requirements and Functional/Design Specifications; Support Factory Acceptance Testing; Identify risk controls and traceability; Execute commissioning and validation test protocols; Perform minor troubleshooting of control logic and instrumentation; Facilitate risk management reviews and FMEA authorization
Seniority
Mid-level, hands-on IC
